Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults
A Phase 1 Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Safety and Immunogenicity of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adult Volunteers
1 other identifier
interventional
218
4 countries
6
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and homologous prime-boost regimens at different time intervals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
Started Oct 2010
Typical duration for phase_1 hiv-infections
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 4, 2010
CompletedFirst Posted
Study publicly available on registry
October 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 17, 2012
December 1, 2012
2.2 years
October 4, 2010
December 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV administered in heterologous and homologous prime-boost regimens.
15-18 months approximately
Secondary Outcomes (1)
Immunogenicity
12 months
Study Arms (12)
Group A
EXPERIMENTALAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 6. Vaccine:Placebo=10:3
Group B
EXPERIMENTALAd35-ENVA at Month 0 followed by Ad26.ENVA.01 at Month 6. Vaccine:Placebo=10:3
Group C
EXPERIMENTALAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=10:3
Group D
EXPERIMENTALAd35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=10:3
Group E
EXPERIMENTALAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Group F
EXPERIMENTALAd35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Group G
EXPERIMENTALAd26.ENVA.01 at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Group H
EXPERIMENTALAd35-ENV at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Group I
EXPERIMENTALAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Group J
EXPERIMENTALAd35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Group K
EXPERIMENTALAd26.ENVA.01 at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Group L
EXPERIMENTALAd35-ENV at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Interventions
Recombinant adenovirus serotype 35 vector vaccine 5x10\^10 vp, delivered IM
Recombinant adenovirus serotype 26 vector vaccine, 5x10\^10 vp delivered IM
Colorless 10mm Tris/HCl buffer
Eligibility Criteria
You may qualify if:
- Healthy male or female, as assessed by a medical history, physical exam, and laboratory tests;
- At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of first vaccination;
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study;
- In the opinion of the Principal Investigator or designee, and based on Assessment of Informed Consent Understanding (AOU) results, has understood the information provided and potential risks linked to vaccination and participation in the trial; written informed consent will be provided by the volunteer before any study-related procedures are performed;
- Willing to undergo HIV testing, risk reduction counselling, receive HIV test results and committed to maintaining low risk behaviour for the trial duration as defined by the protocol;
- If a female of childbearing potential, willing to use an effective non-barrier method of contraception (oral or injectable hormonal contraceptive; intrauterine device \[IUD\]) from screening until at least 4 months after the last study vaccination;
- Assessed by the clinic staff as being at "low risk" for HIV infection on the basis of sexual behaviours within the 12 months prior to enrolment;
- All female volunteers must be willing to undergo pregnancy tests at time points indicated in the protocol and must test negative prior to each study vaccination;
- All sexually active males (unless anatomically sterile) must be willing to use an effective method of contraception (such as consistent condom use) from the day of first vaccination until at least 4 months after the last vaccination;
- Willing to forgo donations of blood or any other tissues during the study and, for those who test HIV positive due to trial vaccination (vaccine-induced HIV seropositivity), until the anti-HIV antibody titers become undetectable.
You may not qualify if:
- Confirmed HIV-1 or HIV-2 infection;
- Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical or inhaled steroids is permitted); immunosuppressive, anticancer, antituberculosis or other medications considered significant by the investigator within the previous 6 months;
- Any clinically significant acute or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study;
- Reported risky behaviour for HIV infection within 12 months prior to vaccination, as defined by the protocol
- If female, pregnant or planning a pregnancy within 4 months after last vaccination; or lactating;
- Asthma requiring high-dose oral or inhaled corticosteroids;
- Fever \> 100.4° F/38.0° C within 72 hours prior to vaccine administration;
- Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions) (Note: A volunteer who states that he or she has easy bruising or bleeding, but does not have a formal diagnosis and has IM injections and blood draws without any adverse experience is eligible);
- History of splenectomy;
- Any abnormal laboratory parameters as defined by the protocol;
- Receipt of live-attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with Investigational Product (within 14 days for live attenuated influenza vaccine \[LAIV\]); or receipt of other vaccine (e.g., influenza, pneumococcal), allergy treatment with antigen injections or tuberculin skin test within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product;
- Receipt of blood transfusion or blood-derived products within the previous 3 months;
- Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study;
- Receipt of another investigational HIV vaccine candidate (Note: receipt of an HIV vaccine control or placebo will not exclude a volunteer from participation if documentation is available and the Medical Monitor gives approval);
- History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulty, angioedema);
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International AIDS Vaccine Initiativelead
- HIV Vaccine Trials Networkcollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Beth Israel Deaconess Medical Centercollaborator
- Ragon Institute of MGH, MIT and Harvardcollaborator
Study Sites (6)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Kenya AIDS Vaccine Initiative
Kangemi, Kenya
Projet San Francisco
Kigali, Rwanda
Desmond Tutu HIV Foundation-Emavundleni Research Centre
Cape Town (Nyanga), South Africa
Aurum Institute
Klerksdorp, South Africa
Perinatal HIV Research Unit
Soweto, South Africa
Related Publications (1)
Baden LR, Karita E, Mutua G, Bekker LG, Gray G, Page-Shipp L, Walsh SR, Nyombayire J, Anzala O, Roux S, Laher F, Innes C, Seaman MS, Cohen YZ, Peter L, Frahm N, McElrath MJ, Hayes P, Swann E, Grunenberg N, Grazia-Pau M, Weijtens M, Sadoff J, Dally L, Lombardo A, Gilmour J, Cox J, Dolin R, Fast P, Barouch DH, Laufer DS; B003-IPCAVD004-HVTN091 Study Group. Assessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention: A Randomized Trial. Ann Intern Med. 2016 Mar 1;164(5):313-22. doi: 10.7326/M15-0880. Epub 2016 Feb 2.
PMID: 26833336DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lindsey Baden, MD
Brigham and Women's Hospital, Boston, MA, USA
- PRINCIPAL INVESTIGATOR
Gaudensia Mutua, MB ChB, MPH
Kenya AIDS Vaccine Initiative, Kangemi, Kenya
- PRINCIPAL INVESTIGATOR
Etienne Karita, MD, M.Sc., MSPH
Projet San Francisco
- PRINCIPAL INVESTIGATOR
Linda-Gail Bekker, MD
Desmond Tutu HIV Foundation-Emavundleni Research Center
- PRINCIPAL INVESTIGATOR
Glenda Gray, MBBCH, FCPaeds(SA)
Perinatal HIV Research Unit
- PRINCIPAL INVESTIGATOR
Liesl Page-Shipp
Aurum Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2010
First Posted
October 6, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 17, 2012
Record last verified: 2012-12