HIV Vaccine Trials Network
Encyclopedia
The HIV Vaccine Trials Network (HVTN) is a non-profit organization
which connects physicians and scientists with activists and community educators for the purpose of conducting clinical trial
s seeking a safe and effective HIV vaccine
. Collaboratively, research professionals and laypeople
review potential vaccines for safety, immune response, and efficacy. The HVTN is the only HIV vaccine research network sponsored nationwide by the American government. It also manages the only large-scale HIV vaccine research trial network in Africa.
The HVTN collaborates with the Division of Acquired Immunodeficiency Syndrome
(DAIDS). Funding comes from the National Institute of Allergy and Infectious Diseases
and National Institutes of Health
, which oversee DAIDS. HVTN is headquartered at the Fred Hutchinson Cancer Research Center
in Seattle. The vaccines being tested come from various producers, both commercial and non-profit. The HVTN is a network for testing vaccines, and while its members may also work in vaccine development for other entities, the mission of the HVTN does not include vaccine design.
on human subjects by asking volunteers to give informed consent
to participate in an experiment by taking drugs which no one has demonstrated to be either safe or effective for use. The Nuremberg Code
, the Declaration of Helsinki
, and the Belmont Report
are legal documents written in layman's terms which local governments use to model their laws for establishing rules for conducting clinical trials, and all contemporary clinical trials of international worth follow all the rules set by these precedents.
However, HIV vaccine research requires more than just these protections, and because of this, from the inception of their research the HVTN has instituted a "community advisory board" (CAB) system in addition to the usual controls. The CAB is similar to an Institutional Review Board
(IRB) in that the researchers facilitate the granting of public data to both entities, but the difference is that the IRB consists of a professional ethics committee and the CAB consists of any community member who wants to supervise the safety, ethics, efficacy, or any other aspect of the research.
The researchers of the HVTN deemed the creation of the CAB necessary for HIV vaccine research when it has not been necessary for other clinical research because the HIV epidemic is especially urgent, new research techniques are available now that did not exist before recent major advances in genetic engineering
, the public is generally overly-willing to volunteer to receive experimental vaccines for this cause, and yet the educational infrastructure already in place to disseminate information about the inherent risk in participating in vaccine research is lacking in society. For too many reasons, there is no precedent for research of this sort on this scale, and without integrating educational programs about this research into existing community institutions, the HVTN simply could not educate people to the required level to make such a fast-moving, expensive, inherently non-commercial research project possible.
in establishing a small-scale vaccine trials unit in Botswana
. A major reason for this project was gathering data about the prevalence of HIV in Africa
and assessing the feasibility of getting grassroots
support for vaccine trials in non-American culture.
In 2007 HVTN started the first large-scale HIV vaccine trials in Africa, with financial assistance from the SA Aids Vaccine Initiative. These studies will last until 2011 and include up to 3000 participants.
One of those trials begun in 2007, the Phambili Trial, was halted in 2007 due to its similarity to the ineffective vaccine used in the American STEP study.
managed by the HVTN. It was thoroughly reviewed when a greater number of participants in the experimental group contracted HIV than the participants in the control group
. The vaccine contained no HIV and no one could have contracted HIV from the vaccine, but there was intense discussion as to whether the vaccine could have increased anyone's risk of contracting HIV. Because the study was stopped early, it probably will never be possible to determine why more participants in the experimental group contracted HIV, but various theories have been proposed.
vaccine regimen will reduce viral load
in individuals who later become infected with HIV. The experimental vaccine used in this study was developed by the Vaccine Research Center
at the National Institutes of Health
(NIH). Study organizers do not expect that this vaccine will prevent HIV infection and thus this vaccine is not planned for licensing
, but it is expected to cause a response that will help researchers decide how to direct future vaccine trials.
Non-profit organization
Nonprofit organization is neither a legal nor technical definition but generally refers to an organization that uses surplus revenues to achieve its goals, rather than distributing them as profit or dividends...
which connects physicians and scientists with activists and community educators for the purpose of conducting clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s seeking a safe and effective HIV vaccine
HIV vaccine
An HIV vaccine that protects vaccinated individuals from HIV infection is the goal of many HIV research programmes. Currently, there is no effective vaccine against HIV, the virus that causes AIDS...
. Collaboratively, research professionals and laypeople
Layman
A layperson or layman is a person who is not an expert in a given field of knowledge. The term originally meant a member of the laity, i.e. a non-clergymen, but over the centuries shifted in definition....
review potential vaccines for safety, immune response, and efficacy. The HVTN is the only HIV vaccine research network sponsored nationwide by the American government. It also manages the only large-scale HIV vaccine research trial network in Africa.
The HVTN collaborates with the Division of Acquired Immunodeficiency Syndrome
Division of Acquired Immunodeficiency Syndrome
The Division of Acquired Immunodeficiency Syndrome is a division of the National Institute of Allergy and Infectious Diseases which is part of the National Institutes of Health. It was formed in 1986 as a part of the to address the national research needs created by the advent and spread of the...
(DAIDS). Funding comes from the National Institute of Allergy and Infectious Diseases
National Institute of Allergy and Infectious Diseases
The National Institute of Allergy and Infectious Diseases is one of the 27 institutes and centers that make up the National Institutes of Health , an agency of the United States Department of Health and Human Services...
and National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
, which oversee DAIDS. HVTN is headquartered at the Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
The Fred Hutchinson Cancer Research Center, is one of the world’s leading cancer research institutes...
in Seattle. The vaccines being tested come from various producers, both commercial and non-profit. The HVTN is a network for testing vaccines, and while its members may also work in vaccine development for other entities, the mission of the HVTN does not include vaccine design.
Community involvement
Typically, researchers conduct clinical researchClinical research
Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use...
on human subjects by asking volunteers to give informed consent
Informed consent
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
to participate in an experiment by taking drugs which no one has demonstrated to be either safe or effective for use. The Nuremberg Code
Nuremberg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.-Background:...
, the Declaration of Helsinki
Declaration of Helsinki
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association . It is widely regarded as the cornerstone document of human research ethics...
, and the Belmont Report
Belmont Report
The Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission...
are legal documents written in layman's terms which local governments use to model their laws for establishing rules for conducting clinical trials, and all contemporary clinical trials of international worth follow all the rules set by these precedents.
However, HIV vaccine research requires more than just these protections, and because of this, from the inception of their research the HVTN has instituted a "community advisory board" (CAB) system in addition to the usual controls. The CAB is similar to an Institutional Review Board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
(IRB) in that the researchers facilitate the granting of public data to both entities, but the difference is that the IRB consists of a professional ethics committee and the CAB consists of any community member who wants to supervise the safety, ethics, efficacy, or any other aspect of the research.
The researchers of the HVTN deemed the creation of the CAB necessary for HIV vaccine research when it has not been necessary for other clinical research because the HIV epidemic is especially urgent, new research techniques are available now that did not exist before recent major advances in genetic engineering
Genetic engineering
Genetic engineering, also called genetic modification, is the direct human manipulation of an organism's genome using modern DNA technology. It involves the introduction of foreign DNA or synthetic genes into the organism of interest...
, the public is generally overly-willing to volunteer to receive experimental vaccines for this cause, and yet the educational infrastructure already in place to disseminate information about the inherent risk in participating in vaccine research is lacking in society. For too many reasons, there is no precedent for research of this sort on this scale, and without integrating educational programs about this research into existing community institutions, the HVTN simply could not educate people to the required level to make such a fast-moving, expensive, inherently non-commercial research project possible.
African HIV vaccine research trials
In 2003 the HVTN partnered with Harvard UniversityHarvard University
Harvard University is a private Ivy League university located in Cambridge, Massachusetts, United States, established in 1636 by the Massachusetts legislature. Harvard is the oldest institution of higher learning in the United States and the first corporation chartered in the country...
in establishing a small-scale vaccine trials unit in Botswana
Botswana
Botswana, officially the Republic of Botswana , is a landlocked country located in Southern Africa. The citizens are referred to as "Batswana" . Formerly the British protectorate of Bechuanaland, Botswana adopted its new name after becoming independent within the Commonwealth on 30 September 1966...
. A major reason for this project was gathering data about the prevalence of HIV in Africa
HIV/AIDS in Africa
HIV/AIDS is a major public health concern and cause of death in Africa. Although Africa is home to about 14.5% of the world's population, it is estimated to be home to 67% of all people living with HIV and to 72% of all AIDS deaths in 2009.-Overview:...
and assessing the feasibility of getting grassroots
Grassroots
A grassroots movement is one driven by the politics of a community. The term implies that the creation of the movement and the group supporting it are natural and spontaneous, highlighting the differences between this and a movement that is orchestrated by traditional power structures...
support for vaccine trials in non-American culture.
In 2007 HVTN started the first large-scale HIV vaccine trials in Africa, with financial assistance from the SA Aids Vaccine Initiative. These studies will last until 2011 and include up to 3000 participants.
One of those trials begun in 2007, the Phambili Trial, was halted in 2007 due to its similarity to the ineffective vaccine used in the American STEP study.
STEP study
STEP was the name for a double-blind randomized controlled trialRandomized controlled trial
A randomized controlled trial is a type of scientific experiment - a form of clinical trial - most commonly used in testing the safety and efficacy or effectiveness of healthcare services or health technologies A randomized controlled trial (RCT) is a type of scientific experiment - a form of...
managed by the HVTN. It was thoroughly reviewed when a greater number of participants in the experimental group contracted HIV than the participants in the control group
Scientific control
Scientific control allows for comparisons of concepts. It is a part of the scientific method. Scientific control is often used in discussion of natural experiments. For instance, during drug testing, scientists will try to control two groups to keep them as identical and normal as possible, then...
. The vaccine contained no HIV and no one could have contracted HIV from the vaccine, but there was intense discussion as to whether the vaccine could have increased anyone's risk of contracting HIV. Because the study was stopped early, it probably will never be possible to determine why more participants in the experimental group contracted HIV, but various theories have been proposed.
HVTN 505
On October 1, 2009, the HVTN began a new clinical trial called HVTN 505. HVTN 505 is a project to examine whether a particular DNA prime/boostvaccine regimen will reduce viral load
Viral load
Viral load is a measure of the severity of a viral infection, and can be calculated by estimating the amount of virus in an involved body fluid. For example, it can be given in RNA copies per milliliter of blood plasma...
in individuals who later become infected with HIV. The experimental vaccine used in this study was developed by the Vaccine Research Center
Vaccine Research Center
The Dale and Betty Bumpers Vaccine Research Center, more commonly known as the Vaccine Research Center , is a department at the U.S. National Institutes of Health which was established to facilitate research in vaccine development...
at the National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
(NIH). Study organizers do not expect that this vaccine will prevent HIV infection and thus this vaccine is not planned for licensing
License
The verb license or grant licence means to give permission. The noun license or licence refers to that permission as well as to the document recording that permission.A license may be granted by a party to another party as an element of an agreement...
, but it is expected to cause a response that will help researchers decide how to direct future vaccine trials.