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New Merck HIV Vaccine Study is Starting
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The beginning of this HIV vaccine study was announced this week. The vaccine will test if it can prevent HIV infection & if a person does get HIV will the vaccine reduce HIV viral load. That is, can it reduce the harm HIV can cause.
This report contains two press releases from the NIH & from Merck, the cosponsors of this study. You will find an explanation at the beginning of this report about the study & the vaccine itself. Later in the report below are Frequently Asked Questions. A list of US study sites is at the end of this report & this report will be stored on the NATAP website at . There are several NY sites including the ACTG at the NYU Medical Center . It's important to bear in mind that some of these study sites are open & some are not as they are still awaiting IRB approval.
The investigational vaccine transports synthetically produced HIV genes into the cells. The delivery of these genes could stimulate the body to generate a cellular immune response to HIV, producing an army of killer cells (called T-cells) that are programmed to recognize and kill HIV-1 infected cells. The idea is to train the immune system to eliminate cells that show signs of HIV infection, thus potentially reducing the damage that HIV can do to the body. If a person later becomes infected with HIV, hopefully the immune system would be prepared to respond.
The investigational vaccine is called MRKAd5 HIV-1 gag/pol/nef. It is composed of an adenovirus vector and an HIV gene insert.
A vector, such as a weakened non-HIV virus, is used to carry a few non-reproducing HIV genes into the body to create an immune response. In this investigational vaccine, the vector is made from adenovirus type 5 (Ad5), a virus that causes the common cold and sore throats, but the vector has been crippled so that it cannot grow or spread in the body or to other people.
A synthetic insert consists of some extra genes added into the vector. In this case, the genes added are HIV genes (gag, pol, and nef).
Neither the virus vector nor the HIV genes can cause HIV or AIDS.
The Merck/HVTN proof-of-concept trial is an international trial, and there will be research sites in a number of countries. The trial is expected to begin enrolling participants around the end of 2004. It will be conducted at 16 study sites in 13 US cities: Boston, MA; Chicago, IL; Atlanta, GA; Denver, CO; Houston, TX; Los Angeles, CA; Miami, FL; New York, NY; Philadelphia, PA; St. Louis, MO; San Francisco, CA; San Juan, PR; and Seattle, WA. It will also be conducted in Santo Domingo, Dominican Republic; Port-au-Prince, Haiti; Iquitos, Peru; Lima, Peru; Toronto, Canada; and Sydney, Australia.
The trial will enroll about 1500 people. Over the course of six months, half of these people will be given three doses of the investigational vaccine, and the other half will be given three doses of a placebo (an injection without any active vaccine) consisting of a saline (salt) solution.
For the rest of their time in the trial (about four more years), participants will be tested for HIV infection every six months. All trial participants will be given state-of-the-art counseling to reduce risk behavior. Because the trial enrolls people whose behavior puts them at high risk for HIV infection, it is expected that some people will become infected. Some of these people will have received placebo, but others may have received the investigational vaccine. These people will be tested to see if the investigational vaccine lowers the level of HIV in the blood.
The Merck/HVTN proof-of-concept trial is a multicenter, randomized, placebo-controlled, doubleblind trial. 'Multicenter' means that people in more than one place volunteer for the study.
'Randomized' means that participants are randomly assigned to get study vaccine or placebo.
'Placebo-controlled' means that some people are given placebo, so the researchers can tell if the investigational vaccine makes a difference. 'Double-blind' means that neither the participants nor the scientists know who is getting the investigational vaccine and who is getting the placebo.
How long will it take to find out if the study vaccine works?
Depending on the results of this trial and other trials, this investigational vaccine might be tested further in a larger trial. Such a trial would test safety in more people, and give a better idea of whether the immune system responds to a vaccine. If results remain promising, more trials would be planned to see if the investigational vaccine helps prevent HIV infection. Participants in this trial may not be eligible for future HIV vaccine trials.
NIH Press Release
NIAID Begins Enrolling Volunteers for Novel HIV Vaccine Study
NIH News
National Institutes of Health
A large clinical trial of a novel HIV vaccine has begun enrolling volunteers at sites in North America, South America, the Caribbean and Australia. Organizers are seeking 1,500 participants.
The trial is co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the pharmaceutical company Merck & Co. Inc. Merck developed the experimental vaccine to stimulate HIV-specific cellular immunity, which prompts the body to produce T cells that kill HIV-infected cells. In previous smaller trials, this vaccine was found to be safe and to induce cellular immune responses against HIV in more than half of volunteers.
"This new study is the first time we have used such a large sample of people to test whether a vaccine that stimulates cellular immunity alone either blocks HIV infection, decreases the level of HIV early in infection or both," says Anthony S. Fauci, M.D., director of NIAID.
This proof-of-concept trial is designed to yield vital information on the potential efficacy of cellular immunity against HIV, although it is not expected to provide enough data to support immediate licensing of the vaccine for public use, says Margaret (Peggy) Johnston, Ph.D., who oversees HIV vaccine research at NIAID's Division of AIDS. The Merck vaccine contains a weakened adenovirus that serves as a carrier for three subtype B HIV genes. Subtype B is the most prevalent HIV subtype in the regions of the study sites. Adenoviruses are among the main causes of upper respiratory tract ailments such as the common cold. Because the vaccine contains only three HIV genes housed in a weakened adenovirus, study participants cannot become infected with HIV or get a respiratory infection from the vaccine.
"If this study finds that the vaccine can prevent or control infection, we will work with Merck to evaluate the vaccine in a larger number of volunteers," adds Dr. Johnston. "We will also work with the company to determine the best vaccine design to test in parts of the world where other subtypes of HIV are circulating."
The study will be conducted jointly by NIAID's multicenter HIV Vaccine Trials Network (HVTN) and by Merck. The lead researchers are Michael Robertson, M.D., of Merck and two HVTN investigators: Susan Buchbinder, M.D., of the San Francisco Department of Public Health and Daniel Fitzgerald, M.D., of Cornell University.
The organizers are seeking healthy, HIV-negative men and women volunteers between the ages of 18 and 45 who are at an increased risk of acquiring HIV. The researchers plan to enroll a significant number of volunteers from populations particularly hard-hit by AIDS, including African Americans and other ethnic minorities.
The trials will take place in the following locations:
* North America: Atlanta, Boston, Chicago, Denver, Houston, Los Angeles, Miami, New York, Philadelphia, St. Louis, San Francisco, Seattle, Toronto
* South America: Iquitos and Lima, Peru
* Caribbean: Santo Domingo, Dominican Republic; Port-au-Prince, Haiti; San Juan, Puerto Rico
* Australia: Sydney
Organizers expect that it will take approximately one year to fully enroll volunteers into the study. NIAID and Merck expect the trial be completed in four-and-a-half years, with results anticipated in 2010. For more information on enrolling, visit HVTN's Web site at www.hvtn.org.
NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.
Media Contact: NIAID News Office
(301) 402-1663
niaidnews@niaid.nih.gov
AVTN Press Release
January 24, 2005
Contact:
Merck & Co., Inc.
Janet Skidmore
908-423-3046
HVTN
Sarah Alexander
206-667-5296
Merck's Investigational HIV/AIDS Vaccine Candidate Advances To Phase II Efficacy Testing in Collaborative Clinical Trial
Public/Private Partnership of Merck and HIV Vaccine Trials Network To Conduct First Efficacy Test of Merck Vaccine Candidate
Link to this website for AVTN Study sites in NY, Boston, Seattle, SF, Philadelphia, Boston, Chicago & St Louis. In addition, Merck has sites in LA, Denver, Atlanta, Miami, Toronto, Sydney. Additional international sites are available:
http://www.hvtn.org/about/sites.html
SEATTLE and WHITEHOUSE STATION, N.J., - The HIV Vaccine Trials Network (HVTN) and Merck & Co., Inc. today announced that they have begun a collaborative Phase II proof-of-concept study using one of Merck's investigational HIV/AIDS vaccine candidates. The trial will be conducted at both Merck and HVTN clinical trial sites in North and South America, the Caribbean, and Australia.
The study -- a collaboration of Merck, the HVTN, and the National Institute of Allergy and Infectious Diseases (NIAID), which funds and supports the HVTN -- combines the strength of Merck's vaccine research efforts and clinical trials expertise with the clinical trials experience and global capacity of the HVTN. The vaccine candidate used in this study has generated strong and durable cellular immune responses against HIV in early human trials. This collaboration could accelerate HIV vaccine development work by guiding scientific decisions for future HIV vaccine trials.
Proof of Concept
The trial is known as a 'proof-of-concept' study because it enables researchers to test the concept that the vaccine candidate prevents HIV infection, or results in lower HIV levels in the blood of those who become infected with HIV. If the concept is proven -- that is, if data generated by the study show that the vaccine candidate provides some protection against HIV, or delays or diminishes the course of HIV infection -- this information will guide future research.
"A proof-of-concept trial is designed to demonstrate the impact of a vaccine candidate on a disease but does not require the large number of participants and the resources required for a Phase III trial, which must enroll many thousands of participants" explains Lawrence Corey, M.D., principal investigator of the HVTN.
The collaborative trial is the first study specifically designed to test the ability of a Merck-developed adenoviral vector-based trivalent vaccine candidate to affect the clinical course of HIV infection. This vaccine candidate is designed to generate a cellular immune response, as opposed to the antibody response typical of most vaccines in use today. The trial is expected to provide vital data about the ability of this vaccine approach to either prevent infection with HIV, and/or to maintain a lower average viral load compared with placebo in individuals who may become infected with HIV during the course of the study.
Information from several different sources, including HIV drug studies and studies of HIV-infected individuals, suggests that maintaining a lower viral load may be associated with clinical benefits to patients. The study will also evaluate whether the investigational vaccine is generally well tolerated by study participants.
"This trial is a critical test of whether the cellular immune response to HIV-1 that is generated by Merck's vaccine candidate is potent enough to impact infection with HIV," said Jeffrey Chodakewitz, M.D., vice president, Clinical Research, at Merck. "We're pleased to extend our ongoing relationship with the HVTN on this important next step in our HIV/AIDS vaccine research program."
This is the second collaboration between Merck, whose scientists have been conducting research to develop an HIV/AIDS vaccine for nearly 20 years, and the HVTN, a global clinical trial network funded and supported by NIAID, one of the National Institutes of Health. Merck and the HVTN are already collaborating on a global clinical trial that is testing the tolerability and immunogenicity of an earlier version of Merck's vaccine candidate. That study is ongoing in 18 cities around the world.
"This proof-of-concept study will involve the cooperation of scientists, government officials, and community leaders from many different countries, underscoring the global response necessary to move the science forward," Dr. Corey added.
Study Details
The multicenter, randomized, double-blind, placebo-controlled Phase II trial has begun enrolling volunteers. Additional study sites are awaiting approval, and will be announced as they are approved by their local Institutional Review Boards. The trial seeks to enroll approximately 1,500 male and female volunteers aged 18 to 45 of diverse racial groups who are at high risk for contracting HIV. All study participants will receive counselling about how to reduce their risk of HIV infection.
The study is testing a Merck vaccine candidate -- known as the MRKAd5 HIV-1 gag/pol/nef, or trivalent, vaccine -- that is based on adenovirus, a common cold virus that has been modified so that it cannot reproduce and cause a cold in humans. The adenovirus is used as a vector, or a delivery vehicle, to transport three synthetically produced HIV genes into the cells. The three HIV genes are known as gag, pol and nef. The delivery of these HIV genes into the cells stimulates the body to generate a potent cellular immune response to HIV, producing an army of killer cells (called T cells) that are programmed to recognize and kill cells infected with HIV. No live HIV is used in the production of the vaccine candidate, so the vaccine candidate cannot cause HIV infection or AIDS.
According to UNAIDS, nearly 40 million people were living with HIV in 2004. With more than 13,000 new HIV infections each day, 95 percent of which occur in developing countries, the global epidemic shows no sign of abating. UNAIDS has reported that a record 3.1 million people died of AIDS in 2004, the highest number for any year since the epidemic began. As with other infectious diseases, development of a vaccine is recognized as the best long-term hope to end the AIDS pandemic. Vaccines are a critical part of an integrated strategy to fight HIV infection, which also includes treatment and prevention.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in over 20 therapeutic categories. The company also devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
About the HIV Vaccine Trials Network
The HVTN is an international collaboration of scientists and institutions whose goal is to accelerate the search for an HIV vaccine by sharing trial results and facilitating parallel, concurrent testing. The HVTN is a unique hybrid that combines the depth and diversity of the academic community and the flexibility of a commercial drug company. Working with industry and government, the HVTN seeks to expedite and coordinate the trial process, advancing vaccine candidates and building a body of knowledge around HIV vaccine trials.
The HVTN is funded and supported by the NIAID of the NIH, an agency of the U.S. Department of Health and Human Services (DHHS). The HVTN comprises more than 25 research institutions worldwide, coordinated from its headquarters at the Fred Hutchinson Cancer Research Center in Seattle.
Merck Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2003, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.
Explaining the study from hvtn.org
"The Step Study" HVTN 502/Merck 023
A Merck/HVTN Proof-of-Concept Vaccine Trial
What is the Merck/HVTN proof-of-concept trial or the Step Trial?
The Merck/HVTN proof-of-concept trial is the name of a clinical trial to test an investigational HIV vaccine. The trial will be run by Merck & Co., Inc., which developed the investigational vaccine, and by the HIV Vaccine Trials Network (HVTN). The investigational vaccine is described in Section 5 below.
The main purposes of this trial are to obtain more information about the safety of the study vaccine in humans and to learn if the study vaccine can prevent HIV infection. For vaccine recipients who become HIV-infected through high-risk behavior, the trial will test whether the study vaccine lowers the level of HIV in the blood.
The products in this trial are not produced from live virus or from HIV-infected human cells. There is no possibility that they contain live (or killed) HIV virus. The investigational vaccine in this trial cannot cause HIV infection.
Who are the people who participate in HIV vaccine trials?
Many types of people participate in HIV vaccine trials. In this trial, all participants must be generally healthy and HIV-negative (free of HIV infection). People have many reasons for joining HIV vaccine trials, including altruism (a desire to help others) and to advance scientific knowledge. Before deciding to enter the trial, potential participants are provided with information about HIV and AIDS, about the reasons for the trial, about possible risks and benefits of participation, and about trial procedures.
Why is this trial being done?
Based on the research that has been conducted to date, the investigational vaccine has shown promising characteristics. After testing the investigational vaccine in the laboratory, in animals, and in some people (to see if it is safe and if it provokes an immune response), researchers are interested in obtaining more information about the safety of the investigational vaccine and learning if the vaccine can prevent HIV infection completely, or at least lower the level of HIV in the blood if infection is not completely prevented.
If the investigational vaccine is effective, will it be licensed after this trial is completed?
This is a "proof of concept" trial. It will not generate sufficient data to support a vaccine licensing application. If the data show that the investigational vaccine affords some protection against HIV, or that it reduces the viral load in those participants who become infected with HIV, this information will guide future research efforts.
What does the study vaccine contain?
The investigational vaccine contains the following:
# A weakened form of adenovirus type 5,
# the HIV genes gag, pol, and nef, and
# saline (salt) solution.
Has this vaccine been studied before?
The investigational vaccine has been tested in more than 250 people. More than 60 people were given the investigational vaccine at the same dose or higher than the dose used in this trial. Two similar HIV investigational vaccines have been tested in more than 450 people.
Before being given to people, the investigational vaccine was tested in mice, rabbits and monkeys.
Who is eligible to participate in this trial?
Participants must be must be HIV-negative (not HIV infected) adults between 18 and 45 years of age, and considered to be at high risk of HIV infection (due to behavior, mainly sexual, that puts them at risk). Special efforts will be made to enroll high-risk women into the trial.
All participants must meet certain medical and non-medical criteria for eligibility, and volunteers are carefully screened to make sure they meet the eligibility requirements. One of the main medical criteria is a low level of pre-existing antibodies against adenovirus type 5, the vector component of the study vaccine. These antibodies may exist even in very healthy people; if a volunteer is ineligible for the trial because of adenovirus antibodies, this does not indicate a health problem.
Is this investigational vaccine safe?
Based on the data from animal studies and earlier trials in people, scientists believe that the investigational vaccine is safe enough to use in this trial. One purpose of this trial is to get more information about the safety of the investigational vaccine.
Previous studies have tested the investigational vaccine in more than 250 people, more than 60 of whom were given the investigational vaccine at the same dose or higher than the dose used in this trial. Two similar HIV vaccines have been tested in more than 450 people.
Before being given to people, the investigational vaccine was tested in mice, rabbits, and monkeys.
While scientists believe that there are no serious safety risks with the investigational vaccine, there is always the possibility that there could be problems that no one expected. This is why this investigational vaccine, like any new drug or vaccine, needs to be tested in participants in a controlled clinical setting. Participants' health and safety will be closely monitored throughout the trial.
Because the investigational vaccine does not contain live HIV virus, there is no way for the study vaccine to cause HIV infection.
How is the safety of the investigational vaccine monitored?
Several groups monitor this trial for safety and to make certain the study is being conducted according to appropriate scientific and ethical standards. These groups include the US Food and Drug Administration (FDA), the US National Institutes of Health (NIH), the HVTN, and Merck & Co., Inc.
Physicians on the team that designed the Merck/HVTN proof-of-concept trial will monitor the safety of the trial. This team carefully considered all of the available information to decide that the investigational vaccine was safe enough to study in this trial.
In addition, there will be an independent Data and Safety Monitoring Board (DSMB); a group of experts not affiliated with Merck and Co., Inc., the HVTN, or the clinical trial investigators, who will carefully monitor the safety of the trial participants. If there are safety concerns, the DSMB can recommend that the trial be modified or stopped.
Are there non-medical (social) risks?
Participants are asked to carefully consider all risks before joining a trial. Some risks are medical (related to health), but there are also non-medical, or social, risks. Trial participation takes time and commitment. It can also lead to complications with others who do not agree with the participant's choice to join the trial, or who do not have enough information about HIV vaccines. For example, some people have reported that being in a trial has upset their spouse, friends or family members.
Participating in a trial may also restrict the volunteer's behavior. For instance, participants are asked not to donate blood, and women should avoid pregnancy during the trial.
Others have experienced discrimination when they told people they were participating in clinical research for an HIV vaccine. In the case of discrimination, study staff can (at a participant's request and with their permission) talk to insurance companies, employers, and others to explain a participant's involvement in a trial.
The investigational vaccine could cause a false positive result on a standard HIV test (see Section 19), and such a result may lead to being treated unfairly by others.
It is important to remember that being given the investigational vaccine does not mean the participant is protected from HIV infection that is due to sexual contact, sharing of injection drug equipment, or any other transfer of blood or bodily fluids. Trial participants will also not know whether they have received the investigational vaccine or the placebo, which is an inactive substance (saline solution) with no protective properties. Participants are therefore counseled to avoid behavior that will put them at risk of HIV infection.
To help avoid problems that could come from participating in a trial, participants will be offered an identification card that shows that they have joined an HIV vaccine study. A number will be listed on the card that may be called for information or for help in resolving problems.
Could the investigational vaccine cause a "false positive" result on an HIV antibody test?
Some investigational vaccines may cause a trial participant to have an HIV test that appears HIV positive. Standard HIV tests look for antibodies (a part of the immune system) that recognize HIV. This investigational vaccine could cause the body to produce these antibodies. In this case, the standard HIV test could show a positive result. If the investigational vaccine causes this result, it does not necessarily mean the study participant is infected with HIV. A false positive means that some tests make a person appear infected; other, more specific tests can prove that there is actually no infection.
Participants are counseled to get HIV testing done only at their trial site, because the site has access to specific tests that can differentiate between false positives and true HIV infection. These tests will be available even after the study ends.
No medical side effects or health problems are associated with a false positive HIV test result. But such a result may lead to being treated unfairly by others. People with a positive HIV test, even a false positive, are not allowed to donate blood. They may also have difficulties with getting insurance, medical/dental care, traveling to other countries, employment, service in the military or Peace Corps, or relationships with friends and family. Clinic staff members are available to help with any difficulty, and services exist to help any study participant with a false positive HIV result.
What will happen to participants if they become HIV-infected from their behavior during this trial?
While the investigational vaccine cannot cause HIV infection there is no guarantee that the investigational vaccine will prevent HIV infection. All participants must be HIV negative when they enroll in the trial.
The investigational vaccine cannot cause infection with HIV. It's important to note that participants can still get infected with HIV through sexual contact, sharing of injection drug equipment, or any other exchange of blood or bodily fluids, even if they are receiving the study vaccine.
Participants are counseled to avoid behavior that would put them at risk of HIV infection. Those who become infected during the trial will stop receiving injections, but clinic staff will ask to continue monitoring their health for the rest of their scheduled time in the trial, and the researchers will test to see how the body controls HIV infection.
There are many drugs that can be used to treat HIV infection, but none of these drugs can cure HIV infection. These drugs are not provided as part of this trial. Participants who become infected during the trial will be referred to an appropriate doctor or medical agency for medical care, including antiretroviral therapy, and counseling.
U.S. Trial Sites
Los Angeles
AIDS Research Alliance*
621-A N. San Vicente Blvd.
West Hollywood, CA 90069
Phone: (310) 358-2429
Fax: (310) 358-2431
San Francisco
San Francisco Dept. of Public Health*
HIV Research Section
25 Van Ness Avenue
Suite 500
San Francsico, CA 94102
Phone: (415) 554-9014
Fax: (415) 621-0641
Saint Louis
Saint Louis University Health Sciences Center*
Center for Vaccine Development
Drummond Hall, Suite 103
3691 Rutger
St. Louis, MO 63110
Phone: (314) 977-9644
Fax: (314) 977-1781
New York
Columbia University*
Mailman School of Public Health
722 W. 168th Street
7 South
New York, NY 10032
Phone: (212) 305-1570
Fax: (212) 342-1907
Subsite
New York Presbyterian Hospital*
Columbia University Medical Center
180 Fort Washington Avenue, HP6
New York, NY 10032
Denver
Denver Public Health
605 Bannock Street
Denver, CO 80204
Phone: (303) 436-7266
Fax: (303) 436-7262
New York
Union Square Project Achieve Clinic* (HVTN #058-004)
853 Broadway, Suite 1111
New York, NY 10003
Phone: (212) 388-0008
Fax: (212) 475-5208
Contact: Kent Curtis
Bronx Project Achieve Clinic* (HVTN #058-005)
391 E. 149th Street
Suite 405
Bronx, NY 10455
Phone: (718) 402-0743
Fax: (718) 402-9874
Contact: Debbie Lucy
New York
NYU School of Medicine*
AIDS Clinical Trials Unit
Bellevue Hospital Center
C & D Building, 5th Floor 512
New York, NY 10016
Phone: (212) 263-6527
Fax: (212) 263-8264
Boston
Fenway Community Health*
7 Haviland Street
Boston, MA 02115
Phone: (617) 927-6140
Fax: (617) 247-3912
Seattle
HIV Vaccine Trials Unit,*
Cabrini Tower
901 Boren, Suite 1320
Seattle, WA 98104
Phone: (206) 667-2300
Fax: (206) 667-2299
Chicago
UIC Project WISH M/C 735*
University of Illinois at Chicago
840 S. Wood, Room B39
Chicago, IL 60612
Phone: (312) 413-5897
Fax: (312) 413-2685
Atlanta
The Hope Clinic of Emory Vaccine Center*
603 Church Street
Decatur, GA 30030
Phone: (404) 377-3719 x14
Fax: (404) 377-6962
Miami
Care Resource*
3510 Biscayne Blvd.
Suite 300
Miami, FL 33137
Phone: (305) 576-1234
Fax: (305) 571-2025
Houston
Center for Clinical Studies*
6655 Travis, Suite 820
Houston, TX 77030
Phone: (713) 528-8818
Fax: (713) 528-8848
San Juan
Maternal Infant Center*
University of Puerto Rico -- Medical Sciences Campus
PO Box. 365067
San Juan, P.R. 00936-5067
Phone: (787) 771-4740
Fax: (787) 771-4739
Houston
Center for Clinical Studies*
2060 Space Park Drive
Suite 200
Houston, TX 77058
Phone: (281) 333-2288
Fax: (281) 335-4605
Philadelphia
University of Pennsylvania*
Center for Studies of Addiction
3535 Market Street, 4th floor, Suite 4000
Phildelphia, PA 19104-3309
Phone: (215) 746-7355
Fax: (215) 746-7377
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