HIV InfectionsNCT01109342
Extended Follow-Up of Participants in Preventive HIV Vaccine Studies in Uganda
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
Trial summary
Two previous studies of an HIV preventive vaccine, the STEP study and the Phambili study, were halted because people who received the vaccine were more likely to become infected with HIV. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 1 siteUganda
- Study dates
- Jul 2010to Jun 2012
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People who received either vaccine or placebo in two previous trials: 1. RV 156A/WRAIR 1078A "A Phase I Clinical Trial To Evaluate The Safety And Immunogenicity Of A Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP Administered Alone Or Administered As A Boost To A Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, In Uninfected Adult Volunteers In Uganda," or 2. RV 172/WRAIR 1218 "A Phase I/II Clinical Trial To Evaluate The Safety And Immunogenicity Of A Multiclade HIV-1 DNA Plasmid Vaccine, VRCHIVDNA016-00-VP, Boosted By A Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP, In HIV Uninfected Adult Volunteers In East Africa." (NCT00123968)
Who may be able to join
- Participated in either of the following studies: (1) RV 156A/WRAIR 1078A, or (2) RV 172/WRAIR 1218
- Able to provide informed consent
Who cannot join
- Incapacitating illness precluding clinic visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extended Follow-Up for Participants in VRC HIV-1 Recombinant Adenovirus-5 Vector Vaccine Studies in Uganda
Two previous studies of an HIV preventive vaccine, the STEP study and the Phambili study, were halted because people who received the vaccine were more likely to become infected with HIV. Why this vaccine failed is still being researched, but one reason may be related to the recombinant Adenovirus type 5 (rAd5) virus vector used in the vaccine. Two trials of another HIV preventive vaccine that used a rAd5 virus vector were conducted in Uganda. This study will obtain follow-up safety information on participants in those trials.
Read the detailed description
Two previous trials of an HIV preventive vaccine, referred to as the MRK rAd5 vaccine, were halted because people receiving the vaccine were at greater risk of HIV infection. The MRK rAd5 vaccine delivered parts of HIV inside a recombinant Ad5 (rAd5) virus vector, which is a modified version of a common virus that does not usually cause serious disease. Analyses of these trials found that the increased risk of HIV infection was seen only in male participants who already had detectable antibodies to Adenovirus type 5 (Ad5).
A different HIV preventive vaccine developed by the Vaccine Research Center (VRC) at the U.S. National Institutes of Health (NIH) also uses a rAd5 virus vector. Although this vaccine, referred to as VRC Ad5, uses a rAd5 virus vector, it is structured and delivered differently than the MRK rAd5 vaccine. In two trials in Uganda it has shown no serious side effects. This study will perform safety follow-ups on participants in these two trials, RV 156A/WRAIR 1078A and RV 172/WRAIR 1218. Participants who received either the vaccine or the placebo will be recruited in order to compare health and HIV status.
Participants in this study will complete eight clinic visits over 1 year and 2 weeks. Four visits will be completed at baseline and after 4, 8, and 12 months. During these visits, participants will be checked for health changes and complete a blood draw. As part of the blood tests performed, participants will be tested for HIV. Every 2 weeks after the four visits mentioned (on Days 14, 134, 254, and 374), participants will return to the clinic to receive the results of their HIV tests. On all eight visits, participants will also receive HIV risk reduction counseling.
- Conditions
- HIV Infections
- Keywords
- HIV Prevention, Vaccine, Recombinant Adenovirus-5, HIV Preventative Vaccine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Recipients | Participants received HIV preventive vaccine VRC-HIV ADV014-00-VP in previous trials RV 156A/WRAIR 1078A or RV 172/WRAIR 1218. | |
| Placebo Recipients | Participants received a placebo vaccine in previous trials RV 156A/WRAIR 1078A or RV 172/WRAIR 1218. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory measures of safety, as defined in protocol
Measured: Measured at baseline and on Days 120, 240, and 360
Product-related adverse and serious adverse experiences
Measured: Measured over 1 year follow-up
HIV and rAdenovirus type 5 (rAd5) T-cell and antibody immune responses
Measured: Measured at baseline and on Days 120, 240, and 360
Risk behaviors
Measured: Measured at baseline and on Days 120, 240, and 360
HIV status
Measured: Measured on Days 14, 134, 154, and 374
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109342
- Sponsor's protocol ID
- RV 283/WRAIR 1631
- Other IDs
- 11698, RV 283
- Status last verified
- Oct 2021
- First submitted
- 21 Apr 2010
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, McElrath MJ, Casimiro DR, Gottesdiener KM, Chodakewitz JA, Corey L, Robertson MN; Step Study Protocol Team. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008 Nov 29;372(9653):1881-1893. doi: 10.1016/S0140-6736(08)61591-3. Epub 2008 Nov 13.
PubMed 19012954McElrath MJ, De Rosa SC, Moodie Z, Dubey S, Kierstead L, Janes H, Defawe OD, Carter DK, Hural J, Akondy R, Buchbinder SP, Robertson MN, Mehrotra DV, Self SG, Corey L, Shiver JW, Casimiro DR; Step Study Protocol Team. HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet. 2008 Nov 29;372(9653):1894-1905. doi: 10.1016/S0140-6736(08)61592-5. Epub 2008 Nov 13.
PubMed 19012957Robb ML. Failure of the Merck HIV vaccine: an uncertain step forward. Lancet. 2008 Nov 29;372(9653):1857-1858. doi: 10.1016/S0140-6736(08)61593-7. Epub 2008 Nov 13. No abstract available.
PubMed 19012958
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Follow-Up for Participants in VRC HIV-1 Recombinant Adenovirus-5 Vector Vaccine Studies in Uganda
- ClinicalTrials.gov ID
- NCT01109342
- Acronym / sponsor ID
- RV 283/WRAIR 1631
- Conditions
- HIV Infections
- Keywords
- HIV Prevention, Vaccine, Recombinant Adenovirus-5, HIV Preventative Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Apr 2010 (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.
Two previous studies of an HIV preventive vaccine, the STEP study and the Phambili study, were halted because people who received the vaccine were more likely to become infected with HIV. Why this vaccine failed is still being researched, but one reason may be related to the recombinant Adenovirus type 5 (rAd5) virus vector used in the vaccine. Two trials of another HIV preventive vaccine that used a rAd5 virus vector were conducted in Uganda. This study will obtain follow-up safety information on participants in those trials.
Detailed description
Two previous trials of an HIV preventive vaccine, referred to as the MRK rAd5 vaccine, were halted because people receiving the vaccine were at greater risk of HIV infection. The MRK rAd5 vaccine delivered parts of HIV inside a recombinant Ad5 (rAd5) virus vector, which is a modified version of a common virus that does not usually cause serious disease. Analyses of these trials found that the increased risk of HIV infection was seen only in male participants who already had detectable antibodies to Adenovirus type 5 (Ad5).
A different HIV preventive vaccine developed by the Vaccine Research Center (VRC) at the U.S. National Institutes of Health (NIH) also uses a rAd5 virus vector. Although this vaccine, referred to as VRC Ad5, uses a rAd5 virus vector, it is structured and delivered differently than the MRK rAd5 vaccine. In two trials in Uganda it has shown no serious side effects. This study will perform safety follow-ups on participants in these two trials, RV 156A/WRAIR 1078A and RV 172/WRAIR 1218. Participants who received either the vaccine or the placebo will be recruited in order to compare health and HIV status.
Participants in this study will complete eight clinic visits over 1 year and 2 weeks. Four visits will be completed at baseline and after 4, 8, and 12 months. During these visits, participants will be checked for health changes and complete a blood draw. As part of the blood tests performed, participants will be tested for HIV. Every 2 weeks after the four visits mentioned (on Days 14, 134, 254, and 374), participants will return to the clinic to receive the results of their HIV tests. On all eight visits, participants will also receive HIV risk reduction counseling.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Recipients | – | –Participants received HIV preventive vaccine VRC-HIV ADV014-00-VP in previous trials RV 156A/WRAIR 1078A or RV 172/WRAIR 1218. |
| Placebo Recipients | – | –Participants received a placebo vaccine in previous trials RV 156A/WRAIR 1078A or RV 172/WRAIR 1218. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People who received either vaccine or placebo in two previous trials: 1. RV 156A/WRAIR 1078A "A Phase I Clinical Trial To Evaluate The Safety And Immunogenicity Of A Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP Administered Alone Or Administered As A Boost To A Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, In Uninfected Adult Volunteers In Uganda," or 2. RV 172/WRAIR 1218 "A Phase I/II Clinical Trial To Evaluate The Safety And Immunogenicity Of A Multiclade HIV-1 DNA Plasmid Vaccine, VRCHIVDNA016-00-VP, Boosted By A Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP, In HIV Uninfected Adult Volunteers In East Africa." (NCT00123968)
Key inclusion criteria (2 listed)
- Participated in either of the following studies: (1) RV 156A/WRAIR 1078A, or (2) RV 172/WRAIR 1218
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Incapacitating illness precluding clinic visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Laboratory measures of safety, as defined in protocol
Time frame: Measured at baseline and on Days 120, 240, and 360
Product-related adverse and serious adverse experiences
Time frame: Measured over 1 year follow-up
HIV and rAdenovirus type 5 (rAd5) T-cell and antibody immune responses
Time frame: Measured at baseline and on Days 120, 240, and 360
Risk behaviors
Time frame: Measured at baseline and on Days 120, 240, and 360
HIV status
Time frame: Measured on Days 14, 134, 154, and 374
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 1 Nov 2021.
- Background: PubMed 19012954Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, McElrath MJ, Casimiro DR, Gottesdiener KM, Chodakewitz JA, Corey L, Robertson MN; Step Study Protocol Team. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008 Nov 29;372(9653):1881-1893. doi: 10.1016/S0140-6736(08)61591-3. Epub 2008 Nov 13.
- Background: PubMed 19012957McElrath MJ, De Rosa SC, Moodie Z, Dubey S, Kierstead L, Janes H, Defawe OD, Carter DK, Hural J, Akondy R, Buchbinder SP, Robertson MN, Mehrotra DV, Self SG, Corey L, Shiver JW, Casimiro DR; Step Study Protocol Team. HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet. 2008 Nov 29;372(9653):1894-1905. doi: 10.1016/S0140-6736(08)61592-5. Epub 2008 Nov 13.
- Background: PubMed 19012958Robb ML. Failure of the Merck HIV vaccine: an uncertain step forward. Lancet. 2008 Nov 29;372(9653):1857-1858. doi: 10.1016/S0140-6736(08)61593-7. Epub 2008 Nov 13. No abstract available.
- Click here for information on study RV 172/WRAIR 1218 (NCT00123968)Link provided by the sponsor.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
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 2 inclusion and 1 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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.
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.
What does the primary outcome measure?
Laboratory measures of safety, as defined in protocol (time frame: Measured at baseline and on Days 120, 240, and 360). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01109342, which also lists 3 linked publications.
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 1 Nov 2021.