HIV InfectionsPhase 1NCT00027365
An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV
A Phase 1 study testing Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A, NefTat and AS02A Adjuvant in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.
Trial summary
The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines. There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS is getting worse. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A, NefTat and AS02A Adjuvant
- Type of treatment
- Vaccines
- How many people
- 84 participants
- Where
- 15 sitesUnited States
- Study dates
- Start not givento Jun 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants may be eligible for this study if they:
- Are between 18 and 60 years of age.
- Are in good general health and meet laboratory test requirements.
- Have a CD4 count of 400 or more cells/mm3.
- Agree to use at least 1 of the following methods of contraception for at least 21 days before enrollment until the last protocol visit: condoms (male or female) with or without a spermicide, diaphragm or cervical cap with spermicide, IUD, or hormonal-based therapy (applies to women who are able to have children).
- Have access to a participating site and are willing to have follow-up for the entire study (12 months).
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- Answer questions about their understanding of the study.
- Do not have hepatitis B or C.
- Are HIV-uninfected.
Who cannot join
- Participants may not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Have recently received a vaccine.
- Have used experimental agents within 30 days before enrollment.
- Have received HIV vaccines or placebo in a previous HIV vaccine study.
- Have received blood products 120 days before HIV screening.
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- Have received immunoglobulin (antibodies) 60 days before HIV screening.
- Have serious reactions to vaccines.
- Have problems with their immune system.
- Have cancer.
- Have used drugs that affect the immune system within the past 6 months.
- Have diabetes.
- Have a thyroid disease.
- Have unstable asthma.
- Are taking anti-tuberculosis drugs.
- Have seizures.
- Have a bleeding disorder.
- Have had their spleen removed.
- Have angioedema (a certain type of body tissue swelling).
- Have active syphilis.
- Have high blood pressure (unless controlled by medication).
- Have mental or emotional problems that make them unsuitable for the study.
- Have any medical, mental, or social condition; job responsibilities; or other responsibility that, in the opinion of the doctor, would interfere with the study.
- Have reactions to components of the vaccines.
- Are at high risk for contracting HIV.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Infectious Diseases Physicians, Inc.
Annandale, Virginia
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research, Project SAVE-Baltimore
Baltimore, Maryland, 21205
Project Brave HIV Vaccine CRS
Baltimore, Maryland
Alabama Vaccine CRS
Birmingham, Alabama, 35294
Brigham and Women's Hosp. CRS
Boston, Massachusetts, 02115
Fenway Community Health Clinical Research Site (FCHCRS)
Boston, Massachusetts, 02115
Vanderbilt Vaccine CRS
Nashville, Tennessee, 37232
NY Blood Ctr./Union Square CRS
New York, New York, 10021
HIV Prevention & Treatment CRS
New York, New York
Miriam Hospital's HVTU
Providence, Rhode Island, 02906
Univ. of Rochester HVTN CRS
Rochester, New York, 14642
San Francisco Vaccine and Prevention CRS
San Francisco, California, 94102
FHCRC/UW Vaccine CRS
Seattle, Washington
Saint Louis Univ. School of Medicine, HVTU
St Louis, Missouri, 63110
NY Blood Ctr./Bronx CRS
The Bronx, New York, 10456
About this study
Official title: A Phase I Safety and Immunogenicity Trial of a Combination Vaccine (NefTat and gp120w61d) Formulated With AS02A (GlaxoSmithKline Biologicals) Given Intramuscularly in HIV-1 Uninfected Adult Participants
The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines.
There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to prevent HIV disease is the best way to try to deal with this situation. Several vaccine products have been tested, but only 2 are still in trial. There is a need for a new product.
Read the detailed description
Despite recent advances in the treatment and prevention of HIV disease, the epidemic is worsening throughout most of the world. HIV/AIDS is the leading cause of death in sub-Saharan Africa and the leading infectious cause of death in the world. An effective and inexpensive vaccine to prevent HIV disease remains as the best option to try to deal with this expanding epidemic. A number of vaccine products have been tested; however, only 2 have progressed to a Phase III trial, underscoring the need for new vaccine strategies.
Prior to study entry, participants have their risk status for HIV infection determined by a series of questions. Further eligibility is determined by results of physical exam, laboratory tests, and further questions. Blood is drawn on each study visit. Participants are assigned randomly to 1 of 4 study groups:
Group I: NefTat or placebo. Groups II, III, and IV: NefTat and gp120 or placebo. Each group receives a different concentration of gp120.
All immunizations are admixed with AS02A adjuvant. Vaccinations are administered intramuscularly at 3 time points (entry, 1 month, and 3 months). Product safety and immunogenicity are performed at designated time points; participants have about 11 clinic visits.
- Conditions
- HIV Infections
- Being tested
- Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A, NefTat, AS02A Adjuvant, gp120W61D
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine, Injections, Intramuscular, HIV Antibodies, HIV-1, HIV Envelope Protein gp120, Gene Products, tat, AIDS Vaccines, Neutralization Tests, Vaccines, Combined, AIDS Seronegativity, Gene Products, nef
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination Vaccine (NefTat and gp120W61D) Formulated with AS02ABiological
NefTatBiological
AS02A AdjuvantDrug
gp120W61DBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2001 (estimated)
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Masking
- Double blind
- Enrolment
- 84 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tom Evans, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027365
- Sponsor's protocol ID
- HVTN 041
- Other IDs
- 10196
- Status last verified
- Oct 2021
- First submitted
- 4 Dec 2001
- Last updated
- 14 Oct 2021
- Results posted
- No
Publications
Vaine M, Wang S, Liu Q, Arthos J, Montefiori D, Goepfert P, McElrath MJ, Lu S. Profiles of human serum antibody responses elicited by three leading HIV vaccines focusing on the induction of Env-specific antibodies. PLoS One. 2010 Nov 9;5(11):e13916. doi: 10.1371/journal.pone.0013916.
PubMed 21085486
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety and Immunogenicity Trial of a Combination Vaccine (NefTat and gp120w61d) Formulated With AS02A (GlaxoSmithKline Biologicals) Given Intramuscularly in HIV-1 Uninfected Adult Participants
- ClinicalTrials.gov ID
- NCT00027365
- Acronym / sponsor ID
- HVTN 041
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine, Injections, Intramuscular, HIV Antibodies, HIV-1, HIV Envelope Protein gp120, Gene Products, tat, AIDS Vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jun 2003 (actual)
- First posted
- 5 Dec 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines.
There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to prevent HIV disease is the best way to try to deal with this situation. Several vaccine products have been tested, but only 2 are still in trial. There is a need for a new product.
Detailed description
Despite recent advances in the treatment and prevention of HIV disease, the epidemic is worsening throughout most of the world. HIV/AIDS is the leading cause of death in sub-Saharan Africa and the leading infectious cause of death in the world. An effective and inexpensive vaccine to prevent HIV disease remains as the best option to try to deal with this expanding epidemic. A number of vaccine products have been tested; however, only 2 have progressed to a Phase III trial, underscoring the need for new vaccine strategies.
Prior to study entry, participants have their risk status for HIV infection determined by a series of questions. Further eligibility is determined by results of physical exam, laboratory tests, and further questions. Blood is drawn on each study visit. Participants are assigned randomly to 1 of 4 study groups:
Group I: NefTat or placebo. Groups II, III, and IV: NefTat and gp120 or placebo. Each group receives a different concentration of gp120.
All immunizations are admixed with AS02A adjuvant. Vaccinations are administered intramuscularly at 3 time points (entry, 1 month, and 3 months). Product safety and immunogenicity are performed at designated time points; participants have about 11 clinic visits.
Study design
- Primary purpose
- Prevention
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Are between 18 and 60 years of age.
- Are in good general health and meet laboratory test requirements.
- Have a CD4 count of 400 or more cells/mm3.
- Agree to use at least 1 of the following methods of contraception for at least 21 days before enrollment until the last protocol visit: condoms (male or female) with or without a spermicide, diaphragm or cervical cap with spermicide, IUD, or hormonal-based therapy (applies to women who are able to have children).
- Have access to a participating site and are willing to have follow-up for the entire study (12 months).
Key exclusion criteria (25 listed)
- Are pregnant or breast-feeding.
- Have recently received a vaccine.
- Have used experimental agents within 30 days before enrollment.
- Have received HIV vaccines or placebo in a previous HIV vaccine study.
- Have received blood products 120 days before HIV screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A | Biological | – |
| NefTat | Biological | – |
| AS02A Adjuvant | Drug | – |
| gp120W61D | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Results publication: PubMed 21085486Vaine M, Wang S, Liu Q, Arthos J, Montefiori D, Goepfert P, McElrath MJ, Lu S. Profiles of human serum antibody responses elicited by three leading HIV vaccines focusing on the induction of Env-specific antibodies. PLoS One. 2010 Nov 9;5(11):e13916. doi: 10.1371/journal.pone.0013916.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Evans study chair
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A, NefTat and AS02A Adjuvant in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00027365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.