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HIV InfectionsPhase 1NCT01264445

Safety and Immunogenicity Study of 2 Investigational Preventive HIV Vaccines

A Phase 1 study testing Adjuvanted GSK investigational HIV vaccine formulation 1, Adjuvanted GSK investigational HIV vaccine formulation 2 and Ad35 investigational HIV vaccine in people with HIV Infections, run by International AIDS Vaccine Initiative at 4 sites in 3 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, tolerability, and immunogenicity of an adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months 1, 2, 3, and 4. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Adjuvanted GSK investigational HIV vaccine formulation 1, Adjuvanted GSK investigational HIV vaccine formulation 2 and Ad35 investigational HIV vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
147 participants
Where
4 sitesin 3 countries
Study dates
Feb 2011to Nov 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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males and females, 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 41st 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 (screening plus 16 months)
  • In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential risks linked to vaccination and participation in the trial. Written informed consent needs to 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
  • If a female of childbearing potential (not menopausal or anatomically sterile), willing to use an effective non-barrier method of contraception (hormonal contraceptive; intra-uterine device), from screening until four months after last vaccination. All female volunteers must be willing to undergo urine pregnancy tests at time points as indicated in the study protocol and must test negative prior to each vaccination.
  • If sexually active male (who is not anatomically sterile), willing to use an effective method of contraception (such as consistent condom use) from the day of first vaccination until 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 after vaccination, until the anti-HIV antibody titres become undetectable

Who cannot join

  • Confirmed HIV-1 or HIV-2 infection
  • Any clinically relevant abnormality on history or examination including history of immunodeficiency, malignancy or autoimmune disease; use of systemic corticosteroids (<2 weeks use of topical or inhaled steroids is permitted); immunosuppressive, anticancer, anti-tuberculosis 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
  • Detection of Ad35-specific serum neutralizing antibody
  • Reported high-risk behaviour for HIV infection within 6 months prior to first vaccination, as defined by the protocol.
  • If female, pregnant or planning a pregnancy within 4 months after last vaccination; or lactating
Show all 22Show fewer
  • Unstable asthma (e.g. sudden acute attacks occurring without an obvious trigger) or asthma requiring:
  • Daily steroid or long acting beta-agonist prevention
  • Hospitalization in the last two years
  • Bleeding disorder that was diagnosed by a physician e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions. (A volunteer who states that he or she has easy bruising or bleeding, but does not have a formal diagnosis and has intramuscular (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 (live attenuated flu vaccine within 14 days) or planned receipt within 60 days after vaccination with Investigational Product; or receipt of other vaccine (e.g. 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 6 months
  • Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study
  • Prior receipt of another investigational HIV vaccine candidate (note: receipt of an HIV vaccine placebo will not exclude a volunteer from participation if documentation is available and the IAVI Medical Monitor gives approval)
  • History of severe local or systemic reactogenicity to vaccines (e.g. anaphylaxis, respiratory difficulty, angioedema)
  • History of severe allergic reactions to any substance requiring hospitalization or emergency medical care (e.g. Steven-Johnson syndrome, bronchospasm or hypotension)
  • Known sensitivity to sulphite, aspirin or aminoglycoside antibiotics (e.g. amikacin, arbekacin, gentamicin, kanamycin, neomycin, netilmicin, paromomycin, streptomycin, tobramycin, etc)
  • Confirmed diagnosis of active hepatitis B (HBsAg), hepatitis C (HCV antibodies), active syphilis or active tuberculosis
  • History of severe neurological disorder, seizure or psychiatric disorder (e.g schizophrenia, severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation)
  • For those volunteers at clinical centres participating in ophthalmic examinations, any clinically significant abnormality found on baseline ophthalmic examination.

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Uganda2 sites

  • Uganda Virus Research Institute-IAVI

    Entebbe

  • Medical Research Council

    Masaka

Other trials in Uganda

Kenya1 site

  • Kenya AIDS Vaccine Initiative

    Nairobi

Other trials in Kenya

Zambia1 site

  • Zambia-Emory HIV Research Project

    Lusaka

Other trials in Zambia

About this study

Official title: A Phase I Double-blinded, Placebo-controlled, Randomized Trial in HIV-uninfected, Healthy Adult Volunteers to Evaluate the Safety and Immunogenicity of an Adjuvanted GSK HIV Vaccine Administered With Ad35-GRIN Investigational Vaccine

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months 1, 2, 3, and 4.

Read the detailed description

Volunteers will be screened up to 42 days before vaccination (up to 90 days for Ad35 neutralizing antibody) and will be followed for 12 months after the last vaccination (16 months total participation).

It is estimated that it will take approximately 5 months to complete enrolment.

Conditions
HIV Infections
Being tested
Adjuvanted GSK investigational HIV vaccine formulation 1, Adjuvanted GSK investigational HIV vaccine formulation 2, Ad35 investigational HIV vaccine, Placebo (saline)
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.

  • Adjuvanted GSK investigational HIV vaccine formulation 1Biological

    Receive at Months 0 and 1

  • Adjuvanted GSK investigational HIV vaccine formulation 2Biological

    Receive at Months 0 and 1

  • Ad35 investigational HIV vaccineBiological

    Receive at Month 0

  • Adjuvanted GSK investigational HIV vaccine formulation 2Biological

    Receive at Months 3 and 4

  • Adjuvanted GSK investigational HIV vaccine formulation 2Biological

    Receive at Months 0, 1, and 4

  • Ad35 investigational HIV vaccineBiological

    Receive at Month 4

  • Ad35 investigational HIV vaccineBiological

    Receive at Months 0, 1, and 4

  • Placebo (saline)Biological

    (Vaccine:Placebo=28:7) Groups A, B, C, and D will all have a placebo comparator component (7 volunteers will receive placebo in each group at the specified months.)

Study groups in NCT01264445
Study groupRoleWhat they receive
Group AExperimentalAdjuvanted GSK investigational HIV vaccine at Months 0 and 1 followed by Ad35-GRIN investigational HIV vaccine at Month 4.
Receives: Biological: Adjuvanted GSK investigational HIV vaccine formulation 1; Biological: Ad35 investigational HIV vaccine; Biological: Placebo (saline)
Group BExperimentalAdjuvanted GSK investigational HIV vaccine at Months 0 and 1 followed by Ad35-GRIN investigational HIV vaccine at Month 4.
Receives: Biological: Adjuvanted GSK investigational HIV vaccine formulation 2; Biological: Ad35 investigational HIV vaccine; Biological: Placebo (saline)
Group CExperimentalAd35-GRIN investigational HIV vaccine at Month 0 followed by Adjuvanted GSK investigational HIV vaccine at Months 3 and 4.
Receives: Biological: Ad35 investigational HIV vaccine; Biological: Adjuvanted GSK investigational HIV vaccine formulation 2; Biological: Placebo (saline)
Group DExperimentalAdjuvanted GSK investigational HIV vaccine and Ad35-GRIN investigational HIV vaccine co-administered (simultaneous administration with separate injections)at Months 0, 1, and 4.
Receives: Biological: Adjuvanted GSK investigational HIV vaccine formulation 2; Biological: Ad35 investigational HIV vaccine; Biological: Placebo (saline)

What is being measured

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

  1. Safety of an adjuvanted HIV protein vaccine in prime-boost combinations with AD35-GRIN or coadministered with AD35-GRIN

    Safety of an adjuvanted (dose escalation for adjvans) HIV protein vaccine given as prime or boost in combination with Ad35-GRIN or co-administered with Ad35-GRIN

    Measured: 16 months

Secondary outcomes (1)

  1. Immunogenicity of an adjuvanted HIV protein vaccine given in different prime-boost regimens with Ad35-GRIN or coadminisitered with Ad35-GRIN

    Measured: 16 months

Timeline

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

  1. First posted21 Dec 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionNov 2012
  4. Study completionNov 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
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01264445
Sponsor's protocol ID
IAVI B002
Status last verified
Feb 2013
First submitted
20 Dec 2010
Last updated
11 Feb 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Omosa-Manyonyi G, Mpendo J, Ruzagira E, Kilembe W, Chomba E, Roman F, Bourguignon P, Koutsoukos M, Collard A, Voss G, Laufer D, Stevens G, Hayes P, Clark L, Cormier E, Dally L, Barin B, Ackland J, Syvertsen K, Zachariah D, Anas K, Sayeed E, Lombardo A, Gilmour J, Cox J, Fast P, Priddy F. A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of an Adjuvanted HIV-1 Gag-Pol-Nef Fusion Protein and Adenovirus 35 Gag-RT-Int-Nef Vaccine in Healthy HIV-Uninfected African Adults. PLoS One. 2015 May 11;10(5):e0125954. doi: 10.1371/journal.pone.0125954. eCollection 2015.

    PubMed 25961283

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Adjuvanted GSK investigational HIV vaccine formulation 1, Adjuvanted GSK investigational HIV vaccine formulation 2 and Ad35 investigational HIV vaccine in people with HIV Infections, run by International AIDS Vaccine Initiative at 4 sites in 3 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 8 inclusion and 22 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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Uganda, Kenya, Zambia. 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?

Safety of an adjuvanted HIV protein vaccine in prime-boost combinations with AD35-GRIN or coadministered with AD35-GRIN (time frame: 16 months). 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 NCT01264445, 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 11 Feb 2013.

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