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HIV InfectionsPhase 1NCT01215149

Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults

A Phase 1 study testing Ad35-ENV vaccine and Ad26.ENVA.01 vaccine in people with HIV Infections, run by International AIDS Vaccine Initiative at 6 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Ad35-ENV vaccine and Ad26.ENVA.01 vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
218 participants
Where
6 sitesin 4 countries
Study dates
Oct 2010to Dec 2012
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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);
  • Confirmed diagnosis of active hepatitis B, hepatitis C or active syphilis;
  • Seizure disorder: A participant who has had a seizure in the last 3 years is excluded. (Not excluded: a participant with a history of seizures who has neither required medications nor had a seizure for 3 years.);
  • Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.

Trial locations and contacts

6 sites in 4 countries.

6 sites in 4 countries

South Africa3 sites

  • Desmond Tutu HIV Foundation-Emavundleni Research Centre

    Cape Town (Nyanga)

  • Aurum Institute

    Klerksdorp

  • Perinatal HIV Research Unit

    Soweto

Other trials in South Africa

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

Kenya1 site

  • Kenya AIDS Vaccine Initiative

    Kangemi

Other trials in Kenya

Rwanda1 site

  • Projet San Francisco

    Kigali

Other trials in Rwanda

About this study

Official title: 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

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.

Read the detailed description

The study is a randomized, double-blind placebo-controlled trial assessing the order of vector priming and boosting (Ad26 versus Ad35), the timing of boost (3 versus 6 months) and the homologous versus heterologous regimen at the 3-month time interval. Groups A-D will be enrolled in Boston, MA, USA, Groups E-H will be enrolled at the East African Clinical Research Centres and Groups I-L will be enrolled at the South African Clinical Research Centres.

Volunteers will be screened up to 56 days before vaccination and will be followed for 12 months after the second vaccination.

Approximately 212 volunteers will be randomized to receive either vaccine or placebo within a group (A-L); Groups A-D, Groups E-H and Groups I-L will be randomized separately. Up to 7% over-enrolment (approximately 15 volunteers) will be allowed to facilitate enrolment.

Conditions
HIV Infections
Being tested
Ad35-ENV vaccine, Ad26.ENVA.01 vaccine, Placebo Control
Keywords
HIV
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad35-ENV vaccineBiological

    Recombinant adenovirus serotype 35 vector vaccine 5x10^10 vp, delivered IM

  • Ad26.ENVA.01 vaccineBiological

    Recombinant adenovirus serotype 26 vector vaccine, 5x10^10 vp delivered IM

  • Placebo ControlBiological

    Colorless 10mm Tris/HCl buffer

Study groups in NCT01215149
Study groupRoleWhat they receive
Group AExperimentalAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 6. Vaccine:Placebo=10:3
Receives: Biological: Ad35-ENV vaccine; Biological: Ad26.ENVA.01 vaccine; Biological: Placebo Control
Group BExperimentalAd35-ENVA at Month 0 followed by Ad26.ENVA.01 at Month 6. Vaccine:Placebo=10:3
Receives: Biological: Ad35-ENV vaccine; Biological: Ad26.ENVA.01 vaccine; Biological: Placebo Control
Group CExperimentalAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=10:3
Receives: Biological: Ad35-ENV vaccine; Biological: Ad26.ENVA.01 vaccine; Biological: Placebo Control
Group DExperimentalAd35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=10:3
Receives: Biological: Ad35-ENV vaccine; Biological: Ad26.ENVA.01 vaccine; Biological: Placebo Control
Group EExperimentalAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Receives: Biological: Ad35-ENV vaccine; Biological: Ad26.ENVA.01 vaccine; Biological: Placebo Control
Group FExperimentalAd35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Receives: Biological: Ad35-ENV vaccine; Biological: Ad26.ENVA.01 vaccine; Biological: Placebo Control
Group GExperimentalAd26.ENVA.01 at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Receives: Biological: Ad26.ENVA.01 vaccine; Biological: Placebo Control
Group HExperimentalAd35-ENV at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Receives: Biological: Ad35-ENV vaccine; Biological: Placebo Control
Group IExperimentalAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Receives: Biological: Ad35-ENV vaccine; Biological: Ad26.ENVA.01 vaccine; Biological: Placebo Control
Group JExperimentalAd35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Receives: Biological: Ad35-ENV vaccine; Biological: Ad26.ENVA.01 vaccine; Biological: Placebo Control
Group KExperimentalAd26.ENVA.01 at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Receives: Biological: Ad26.ENVA.01 vaccine; Biological: Placebo Control
Group LExperimentalAd35-ENV at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Receives: Biological: Ad35-ENV vaccine; Biological: Placebo Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 15-18 months approximately

Secondary outcomes (1)

  1. Immunogenicity

    • To evaluate the immunogenicity of Ad26.ENVA.01 and Ad35-ENV administered in heterologous prime-boost regimens at 3 versus 6 month intervals
    • To evaluate the immunogenicity of Ad26.ENVA.01 and Ad35-ENV administered in heterologous and homologous prime-boost regimens at 3 month interval
    • To evaluate anti-vector immunity induced by Ad26.ENVA.01 and Ad35-ENV administered in heterologous and homologous prime-boost regimens

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01215149
Sponsor's protocol ID
IAVI B003/ IPCAVD-004
Status last verified
Dec 2012
First submitted
4 Oct 2010
Last updated
17 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26833336

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad35-ENV vaccine and Ad26.ENVA.01 vaccine in people with HIV Infections, run by International AIDS Vaccine Initiative at 6 sites in 4 countries.

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 10 inclusion and 18 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Africa, United States, Kenya, Rwanda. 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.

What does the primary outcome measure?

Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 15-18 months approximately). 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 NCT01215149, 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 17 Dec 2012.

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