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HIV/AIDSPhase 1EV06NCT02376582

Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS

A Phase 1 study testing DNA and AIDSVAX B/E in people with HIV/AIDS, run by EuroVacc Foundation at 2 sites in Uganda.

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 primary objective of the proposed phase I trial is to evaluate the safety and tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen. Though both DNA-HIV-PT123 and AIDSVAX®B/E and the combination of the two vaccines have been evaluated in humans and have shown to be safe and well tolerated, this is the… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
DNA and AIDSVAX B/E
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesUganda
Study dates
Sep 2014to Jan 2016
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • HIV-1 uninfected adults aged 18-45 years, as confirmed by a medical history, physical exam, and laboratory tests during screening
  • In 50% of study volunteers, positive for S. mansoni infection but negative for other helminth infections.
  • In 50% of study volunteers, negative for S. mansoni and other helminth infections
  • Willing to forgo treatment with praziquantel until after completion of week 26 visit in the trial.
  • Able and willing to provide written informed consent prior to screening
  • Aged 18 through 45 years on the day of first vaccination
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  • Able and willing to complete screening (about 1 month) and available for the planned follow-up period (9months)
  • Willing to undergo HIV testing, risk reduction counselling, receive HIV test results and committed to maintaining low risk behaviour for the trial duration
  • If female of childbearing potential (not menopausal or sterilised), willing to use a non-barrier contraceptive method from screening through the end of the study. Acceptable contraceptive methods include hormonal contraceptives (injection, transdermal patch, or implant) and intrauterine device (IUD).
  • Willing to provide blood, urine and stool samples for laboratory examination

Who cannot join

  • HIV-1 infection
  • Infection with other helminths
  • Symptomatic and asymptomatic malaria infection (presence of malaria parasites on thick blood smear)
  • Treatment with praziquantel in the past 3 months
  • S. mansoni egg count of>2000 eggs per gram of stool
  • Clinically significant acute or chronic illness at the time of randomization.
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  • Any clinically relevant abnormality on history or examination
  • Use of immunosuppressive medication (other than inhaled or topical immunosuppressants)
  • Receipt of immunoglobulin within past 60 days
  • Abnormal laboratory values as specified below from blood collected within 28 days prior to randomization:
  • Hematology
  • Haemoglobin <9.0 g/dL or<5.59 mmol/L
  • Absolute Neutrophil Count (ANC): < 1000/mm3or < 1.0 x 109/L
  • Absolute Lymphocyte Count (ALC): ≤ 500/mm3or ≤ 0.5 x 109/L
  • Platelets: ≤ 90,000 ≥ 550,000/mm3or ≤ 90 x 109 ≥ 550 x 109/L
  • Chemistry
  • Creatinine: > 1. 1 x ULN
  • AST: >2.6 x ULN
  • ALT: >2.6 x ULN
  • Urinalysis: abnormal dipstick confirmed by microscopy
  • Protein 2+ or more
  • Blood 2+ or more (not due to menses)
  • Reported high-risk behaviour for HIV infection within 3 months prior to first vaccination, as defined by:
  • Unprotected sexual intercourse with a known HIV-infected person, a partner known to be at high risk of HIV infection or a casual partner
  • Unprotected sexual intercourse with more than one sexual partner
  • Engagement in sex work for money or drugs
  • Use of recreational drugs (e.g. marijuana) and/or weekly or more frequent alcohol use
  • Current or past STI
  • History or evidence of autoimmune disease.
  • Positive for Hepatitis B surface antigen (HbsAg), positive for antibodies to Hepatitis C virus (HCV) or active syphilis.
  • Receipt of blood or blood products within the previous 6 months
  • History of severe allergic reactions to any substance requiring hospitalization or emergency medical care (e.g. Steven-Johnson syndrome, bronchospasm or hypotension)
  • Prior or current participation in another investigational agent trial
  • Current anti-tuberculosis (TB) prophylaxis or therapy
  • If female, currently pregnant (positive serum or urine pregnancy test), planning to get pregnant in the next 9months or lactating
  • History or evidence of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may compromise the volunteer's safety or interfere with the evaluation of the safety or immunogenicity of the vaccine

Trial locations and contacts

2 sites in 1 country.

Uganda2 sites

  • Uganda Virus Research Institute - International AIDS Vaccine Initiative HIV Vaccine Program (UVRI-IAVI)

    Entebbe

  • Medical Research Council (MRC) /Uganda Virus Research Institute (UVRI)

    Masaka

Other trials in Uganda

About this study

Official title: A Phase I Double Blind Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of the Combination of DNA-HIV-PT123 and AIDSVAX®B/Ein HIV-1-uninfected Adult Participants With or Without Underlying Schistosoma Mansoni Infection

The primary objective of the proposed phase I trial is to evaluate the safety and tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen. Though both DNA-HIV-PT123 and AIDSVAX®B/E and the combination of the two vaccines have been evaluated in humans and have shown to be safe and well tolerated, this is the first time the combination regimen is being evaluated in HIV-1 uninfected African populations with and without S. mansoni. The secondary objective of the trial is to evaluate the effect of S. mansoni infection on the immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX® B/E vaccine regimen. Successful vaccination against most viruses requires efficient Th1 response. There is evidence that helminth infections skew the host immune system of human and animals to T-helper type 2 (Th2) and induce immunosuppression. Therefore, there is a potential that helminth infected populations may not generate the desired immune responses to vaccines designed to drive Th1-type and cytotoxic T-cell responses.

Furthermore, the influence of helminth infections on the development of protective antibody responses remains unclear. Limited data in animal models suggests that worm infections reduced efficacy of vaccines.

The proposed vaccine trial will generate safety, tolerability and immunogenicity data of a vaccination regimen with simultaneous administration of a candidate HIV DNA vaccine (DNA-HIV-PT123) and a gp120 protein vaccine (AIDSVAX®B/E). This will be the first HIV vaccine trial to prospectively evaluate the impact of the S. mansoni infection on safety and immune responses to HIV vaccines.

Conditions
HIV/AIDS
Being tested
DNA, AIDSVAX B/E
Keywords
HIV/AIDS vaccine, helminth infection, Impact of co-infection
Medical subject headings
Acquired Immunodeficiency Syndrome, Trematode Infections

What participants receive

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

  • DNABiological

    Also called DNA-HIV-PT123

    DNA co-administered with protein at month 0, 1 and 6

  • AIDSVAX B/EBiological

    Protein co-administered with DNA at month 0,1 and 6

Study groups in NCT02376582
Study groupRoleWhat they receive
DNA and proteinExperimental4mg DNA and 600 mcg protein formulated with Alum co-administration (IM) at Month 0, 1 and 6 in Schisto infected individuals
Receives: Biological: DNA; Biological: AIDSVAX B/E
Vaccination without S. mansoni infectionActive comparatorDNA Protein
Receives: Biological: DNA; Biological: AIDSVAX B/E

What is being measured

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

  1. Proportion of volunteers with local and systemic reactogenicity events during a 7 day follow up period after each vaccination

    Measured: 7 days post each vaccination

  2. Proportion of volunteers with adverse events during a 4 week follow up period after each vaccination

    Measured: 4 weeks post each vaccination

  3. Proportion of volunteers with abnormal laboratory parameters during a 4 week follow up period after each vaccination

    Measured: 4 weeks post each vaccination

  4. Proportion of volunteers with serious adverse events throughout the study period

    Measured: Each participant will be followed for 9 months

Secondary outcomes (4)

  1. Proportion of volunteers with HIV-specific CD4+ and CD8+ T cell responses as assessed by IFN-g ELISpot and multiparameter flow cytometry (IFN-g TNF-a and IL-2) 2 weeks after the 2nd and 3rd vaccination

    Measured: two weeks post 2nd and 3 vaccination

  2. Magnitude of HIV-specific CD4+ and CD8+ T cell responses as assessed by IFN-g ELISpot and multiparameter flow cytometry (IFN-g TNF-a and IL-2) 2 weeks after the 2nd and 3rd vaccination

    Measured: two weeks post 2nd and 3 vaccination

  3. HIV-specific Env binding Antibody response 2 weeks after the 2nd and 3rd vaccination

    Measured: two weeks post 2nd and 3 vaccination

  4. Magnitude and breadth of neutralizing antibody responses against tier 1 and tier 2 HIV-1 isolates 2 weeks after the 2nd and 3rd vaccination

    Measured: two weeks post 2nd and 3 vaccination

Timeline

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

  1. First posted3 Mar 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

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
Double blind
Who is masked
Participant, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02376582
Sponsor's protocol ID
EV06
Acronym
EV06
Status last verified
Jan 2016
First submitted
18 Jul 2014
Last updated
22 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DNA and AIDSVAX B/E in people with HIV/AIDS, run by EuroVacc Foundation at 2 sites in Uganda.

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 36 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 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in 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?

Proportion of volunteers with local and systemic reactogenicity events during a 7 day follow up period after each vaccination (time frame: 7 days post each vaccination). The study lists 4 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 NCT02376582.

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 22 Jan 2016.

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