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HIV InfectionsPhase 1NCT01496989

Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers

A Phase 1 study testing HIV-MAG (3,000mcg), GENEVAX® IL-12 (100mcg) and GENEVAX® IL-12 (1000mcg) in people with HIV Infections, run by International AIDS Vaccine Initiative at 3 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 multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in low-risk for HIV-uninfected healthy adults. 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?
HIV-MAG (3,000mcg), GENEVAX® IL-12 (100mcg) and GENEVAX® IL-12 (1000mcg)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
3 sitesin 3 countries
Study dates
Dec 2011to Mar 2013
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 adults,
  • 18 to 50 years of age (21 to 50 years of age for volunteers in Rwanda),
  • who do not report high-risk behaviour for HIV infection,
  • who are available for the duration of the trial,
  • who are willing to undergo HIV testing,
  • use an effective method of contraception, and
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  • who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent.
  • Principal exclusion criteria:
  • confirmed HIV infection,
  • pregnancy and lactation,
  • significant acute or chronic disease,
  • clinically significant laboratory abnormalities,
  • recent vaccination or receipt of a blood product,
  • previous receipt of an HIV vaccine, and
  • previous severe local or systemic reactions to vaccination or history of severe allergic reactions.

Who cannot join

None listed.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Kenya1 site

  • Kenya AIDS Vaccine Initiative, Kangemi

    Nairobi

Other trials in Kenya

Rwanda1 site

  • Projet San Francisco

    Kigali

Other trials in Rwanda

Uganda1 site

  • Uganda Virus Research Institute-IAVI

    Entebbe

Other trials in Uganda

About this study

Official title: A Phase 1 Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate Safety and Immunogenicity of a Multiantigen HIV (HIV-MAG) pDNA Vaccine With or Without Human IL-12 pDNA GENEVAX® IL-12) and Ad35-GRIN/ENV Vaccine in HIV-Uninfected, Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in low-risk for HIV-uninfected healthy adults.

Read the detailed description

The study is a randomized, double-blind placebo-controlled trial assessing the safety and tolerability of HIV-MAG with or without co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM) followed by Ad35-GRIN/ENV in each of four different regimens. An additional group will evaluate the safety and tolerability of Ad35-GRIN/ENV followed by HIV-MAG with co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM).

Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the first vaccine administration. It is anticipated that it will take approximately 3 months to enrol the study. Approximately 75 volunteers (60 vaccine/15 placebo recipients) will be included in the study.

Conditions
HIV Infections
Being tested
HIV-MAG (3,000mcg), GENEVAX® IL-12 (100mcg), GENEVAX® IL-12 (1000mcg), Ad35-GRIN/ENV
Keywords
HIV, AIDS, HIV vaccine, HIV prevention
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

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

  • HIV-MAG (3,000mcg)Biological

    Delivered intramuscularly by in vivo electroporation

  • GENEVAX® IL-12 (100mcg)Biological

    Co-administered with HIV-MAG, delivered intramuscularly by in vivo electroporation

  • GENEVAX® IL-12 (1000mcg)Biological

    Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation

  • Ad35-GRIN/ENVBiological

    (2x10^10vp) Delivered intramuscularly by standard needle injection

Study groups in NCT01496989
Study groupRoleWhat they receive
Group 1: HIV-MAG followed by Ad35-GRIN/ENVExperimentalHIV-MAG (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo = 12/3)
Receives: Biological: HIV-MAG (3,000mcg); Biological: Ad35-GRIN/ENV
Group 2: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENVExperimentalHIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo=12/3)
Receives: Biological: HIV-MAG (3,000mcg); Biological: GENEVAX® IL-12 (100mcg); Biological: Ad35-GRIN/ENV
Group 3: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENVExperimentalHIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo= 12/3)
Receives: Biological: HIV-MAG (3,000mcg); Biological: GENEVAX® IL-12 (1000mcg); Biological: Ad35-GRIN/ENV
Group 4: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENVExperimentalHIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 0 followed by Ad35-GRIN/ENV (IM) at Month 4. (Vaccine:Placebo=12/3)
Receives: Biological: HIV-MAG (3,000mcg); Biological: GENEVAX® IL-12 (1000mcg); Biological: Ad35-GRIN/ENV
Group 5: Ad35-GRIN/ENV followed by HIV-MAG+GENEVAX® IL-12ExperimentalAd35-GRIN/ENV (IM) at Month 0 followed by HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 4. (Vaccine:Placebo=12/3)
Receives: Biological: HIV-MAG (3,000mcg); Biological: GENEVAX® IL-12 (1000mcg); Biological: Ad35-GRIN/ENV

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 HIV-MAG, GENEVAX® IL-12, and Ad35-GRIN/ENV administered in five heterologous prime-boost regimens.

    Measured: 13 months approximately

Secondary outcomes (1)

  1. Immunogenicity

    To assess (qualitative and quantitative) immune responses elicited by the different 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 posted22 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionMar 2013

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
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01496989
Sponsor's protocol ID
IAVI B004
Status last verified
Aug 2013
First submitted
19 Dec 2011
Last updated
2 Sep 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Mpendo J, Mutua G, Nanvubya A, Anzala O, Nyombayire J, Karita E, Dally L, Hannaman D, Price M, Fast PE, Priddy F, Gelderblom HC, Hills NK. Acceptability and tolerability of repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine among healthy African participants in a phase 1 randomized controlled trial. PLoS One. 2020 May 29;15(5):e0233151. doi: 10.1371/journal.pone.0233151. eCollection 2020.

    PubMed 32469893

  • Mpendo J, Mutua G, Nyombayire J, Ingabire R, Nanvubya A, Anzala O, Karita E, Hayes P, Kopycinski J, Dally L, Hannaman D, Egan MA, Eldridge JH, Syvertsen K, Lehrman J, Rasmussen B, Gilmour J, Cox JH, Fast PE, Schmidt C. A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of Electroporated HIV DNA with or without Interleukin 12 in Prime-Boost Combinations with an Ad35 HIV Vaccine in Healthy HIV-Seronegative African Adults. PLoS One. 2015 Aug 7;10(8):e0134287. doi: 10.1371/journal.pone.0134287. eCollection 2015.

    PubMed 26252526

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HIV-MAG (3,000mcg), GENEVAX® IL-12 (100mcg) and GENEVAX® IL-12 (1000mcg) in people with HIV Infections, run by International AIDS Vaccine Initiative at 3 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 15 inclusion and 0 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 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Kenya, Rwanda, 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.

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: 13 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 NCT01496989, which also lists 2 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 2 Sep 2013.

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