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Human Immunodeficiency Virus InfectionsPhase 2TGC14FNCT00888446

Safety and Immunogenicity Study of tgAAC09, an HIV Vaccine in an Adeno-associated Virus (AAV) Capsid

A Phase 2 study testing tgAAC09 and Formulation buffer in people with Human Immunodeficiency Virus Infections and HIV Infections, run by International AIDS Vaccine Initiative at 5 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

This phase 2 study will evaluate the safety, immunogenicity and optimal timing of two injections at three dose levels of the tgAAC09 vaccine in healthy volunteers. Study volunteers will receive two intramuscular injections of tgAAC09 or placebo at Months 0 and 6 (groups A, C, E and G) or at Months 0 and 12 (groups B… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
tgAAC09 and Formulation buffer
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
5 sitesin 3 countries
Study dates
Oct 2005to Dec 2007
Phase
Phase 2
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
  • Age at least 18 years on the day of screening and no greater than 50 years on the day of the first study injection
  • Willing to comply with the requirements of the protocol and available for follow up for the planned duration of the study
  • Able and willing to give informed consent.
  • Willing to undergo HIV testing, counseling and receive results
  • If sexually active female of child-bearing potential (not menopausal or anatomically sterile), willing to use an effective method of contraception (hormonal contraceptives; intrauterine contraceptive device (IUCD); condoms; anatomical sterility in self or partner) from screening until at least four months after last study injection and willing to undergo urine pregnancy tests at screening, prior to each injection and four months after the last injection
  • If sexually active male, willing to use a method of contraception (such as condoms) from screening until four months after the last study injection

Who cannot join

  • HIV-1 or HIV-2 infection
  • Active tuberculosis
  • Clinically relevant abnormality on history or examination including history of immunodeficiency, or cancer, or autoimmune disorder
  • Use of systemic corticosteroids, immunosuppressive or anticancer medications in the last six months
  • Chronic condition that, in the opinion of the investigator or the designated trial physician, would make the volunteer unsuitable for the study
  • Any of the following abnormal laboratory parameters:
Show all 28Show fewer
  • Hemoglobin <9.0 g/dL (females), <12.0 g/dL (males)
  • Absolute Neutrophil Count (ANC): ≤ 999/mm3
  • Absolute Lymphocyte Count (ALC): ≤ 500/mm3
  • Platelets: decreased ≤ 90,000 or increased ≥ 550,000/mm3
  • Creatinine: > 1.4 x ULN
  • AST: >3.0 x ULN
  • ALT: >3.0 x ULN
  • Urine dipstick: blood = 2+ or more (except in menstruating females); protein = 2+ or more
  • Any of the following high-risk behaviors:
  • Had unprotected vaginal or anal sex with a known HIV positive person in the past six months
  • Had unprotected vaginal or anal sex with a casual partner (i.e. no continuing established relationship) in the past six months
  • Engaged in sex work for money or drugs in the past six months
  • Used injection drugs illegally in the past six months
  • Acquired a sexually transmitted infection (STI) in the past six months
  • If female, pregnant, lactating or planning a pregnancy within four months after last study injection
  • Receipt of live attenuated vaccine within 30 days or other vaccine within 14 days of the first study injection
  • Receipt of blood transfusion or blood products six months prior to the first study injection
  • Participation in another clinical trial of an investigational product currently or within last 12 weeks of first study injection or expected participation during this study
  • Prior receipt of an investigational HIV vaccine
  • History of severe local or systemic reaction to vaccination(s) or history of severe allergic reactions
  • History of major neurological or psychiatric disorders
  • Positive for hepatitis B surface antigen, active untreated syphilis (confirmed by treponemal test such as TPHA in addition to nontreponemal test such as RPR) or other active sexually transmitted diseases

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

South Africa3 sites

  • Desmond Tutu HIV Centre Cape Town

    Cape Town, South Africa, 7920

  • Medunsa

    South Africa, South Africa, 0204

  • Perinatal HIV Research Unit, Baragwanath Hospital

    Soweto, South Africa, 2013

Other trials in South Africa

Uganda1 site

  • Uganda Virus Research Institute

    Entebbe, Entebbe

Other trials in Uganda

Zambia1 site

  • Zambia-Emory HIV Research Project (ZEHRP)

    Lusaka, Lusaka Province

Other trials in Zambia

About this study

Official title: Phase II, Placebo-controlled, Double-blind, Dose-escalation/Dose-optimization Trial to Evaluate Safety and Immunogenicity of tgAAC09, an HIV Vaccine Containing Clade C Gag-PR-ΔRT DNA in an Adeno-associated Virus (AAV) Capsid

This phase 2 study will evaluate the safety, immunogenicity and optimal timing of two injections at three dose levels of the tgAAC09 vaccine in healthy volunteers. Study volunteers will receive two intramuscular injections of tgAAC09 or placebo at Months 0 and 6 (groups A, C, E and G) or at Months 0 and 12 (groups B, D and F) and be followed for a total of 18 months following the first injection with the exception of group G in which volunteers will be followed for 12 months after the first injection (6 months after the second injection). This study will explore whether boosting is possible, and compare a shorter and more practical six-month time interval with a twelve-month time interval.

Read the detailed description

The study design will also assess the effect of the presence of anti-AAV2 capsid neutralizing antibodies at the time of vaccination on the safety and immunogenicity of tgAAC09. Since the prevalence of pre-existing neutralizing antibodies to AAV2 capsid is high (IAVI and Targeted Genetics, data on file), this protocol amendment adds Group G which is composed of volunteers who have documented pre-existing anti-AAV2 capsid neutralizing antibodies titers ≤ 1/8. This will assure that there are sufficient numbers of volunteers with and without antibodies for a useful comparison.

Being tested
tgAAC09, Formulation buffer
Keywords
HIV, HIV seronegativity, 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.

  • tgAAC09Biological

  • tgAAC09Biological

  • tgAAC09Biological

  • Formulation bufferOther

    Sterile isotonic buffered salt solution

Study groups in NCT00888446
Study groupRoleWhat they receive
Group AExperimentalNumber of Vaccine Recipients: 10 Dosage level 3 x 10^10 DRP Month 0 + 6
Receives: Biological: tgAAC09
Group BExperimentalNumber of Vaccine Recipients: 10 Dosage level 3 x 10^10 DRP Month 0+12
Receives: Biological: tgAAC09
Group CExperimentalNumber of Vaccine Recipients: 10 Dosage level 3 x 10^11 DRP Month 0+6
Receives: Biological: tgAAC09
Group DExperimentalNumber of Vaccine Recipients: 10 Dosage level 3 x 10^11 DRP Month 0+12
Receives: Biological: tgAAC09
Group EExperimentalNumber of Vaccine Recipients: 10 Dosage level 3 x 10^12 DRP Month 0+6
Receives: Biological: tgAAC09
Group FExperimentalNumber of Vaccine Recipients: 10 Dosage level 3 x 10^12 DRP Month 0+12
Receives: Biological: tgAAC09
Group GExperimentalNumber of Vaccine Recipients: 10 Preselected for baseline AAV neutralization titers of <1/8 Dosage level 3 x 10^12 DRP Month 0+6
Receives: Biological: tgAAC09
PlaceboPlacebo comparator3 volunteers will receive placebo matched to each experimental group.
Receives: Other: Formulation buffer

What is being measured

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

  1. Safety: proportion of volunteers with severe local and systemic reactions, proportion of volunteers with other SAEs (including laboratory abnormalities) related to study vaccine, number of volunteers with SAEs related to study vaccine

    Measured: 18 months

  2. Proportion of volunteers with HIV-1 specific T- cell responses quantified by γ-IFN ELISPOT and magnitude of the response, and proportion of volunteers with HIV-1 specific binding antibodies and magnitude of the response

    Measured: 18 months

Secondary outcomes (7)

  1. Safety: high versus low or negative titres of neutralizing antibodies to AAV2 at the time of each vaccination

    Measured: 18 months

  2. Immunogenicity: proportion of volunteers with HIV-1 specific T- cell responses by γ-IFN CFC or other T-cell assays

    Measured: 18 months

  3. Immunogenicity endpoints in volunteers with high versus low or negative titres of neutralizing antibodies to AAV2 at the time of each vaccination

    Measured: 18 months

  4. Immunogenicity endpoints in volunteers with versus without four-fold or greater increase in titres of neutralizing antibodies to AAV2 after vaccination

    Measured: 18 months

  5. Immunogenicity endpoints after the second study injection, compared with the first study injection

    Measured: 18 months

  6. Immunogenicity endpoints after the second study injection following a twelve-month interval compared to a six-month interval

    Measured: 18 months

  7. Vaccine biodistribution: presence and persistence of vaccine in peripheral blood mononuclear cells (PBMC), saliva, nasal swabs, urine and semen or cervical/vaginal secretions

    Measured: 18 months

Timeline

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

  1. First posted27 Apr 2009 (estimated)
  2. Study startOct 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00888446
Sponsor's protocol ID
IAVI A002
Acronym
TGC14F
Status last verified
Dec 2012
First submitted
23 Apr 2009
Last updated
17 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Vardas E, Kaleebu P, Bekker LG, Hoosen A, Chomba E, Johnson PR, Anklesaria P, Birungi J, Barin B, Boaz M, Cox J, Lehrman J, Stevens G, Gilmour J, Tarragona T, Hayes P, Lowenbein S, Kizito E, Fast P, Heald AE, Schmidt C. A phase 2 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 vaccine based on adeno-associated virus. AIDS Res Hum Retroviruses. 2010 Aug;26(8):933-42. doi: 10.1089/aid.2009.0242.

    PubMed 20666584

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tgAAC09 and Formulation buffer in people with Human Immunodeficiency Virus Infections and HIV Infections, run by International AIDS Vaccine Initiative at 5 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 7 inclusion and 28 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 5 sites in South Africa, Uganda, 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: proportion of volunteers with severe local and systemic reactions, proportion of volunteers with other SAEs (including laboratory abnormalities) related to study vaccine, number of volunteers with SAEs related to study vaccine (time frame: 18 months). The study lists 2 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 NCT00888446, 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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