AzTrials
AzTrials

HIV InfectionsPhase 2NCT01371175

A Phase IIA Trial to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Followed by an MVA HIV-1 Vaccine in HIV-uninfected Volunteers

A Phase 2 study testing DNA.HIVA and MVA.HIVA in people with HIV Infections, run by International AIDS Vaccine Initiative at 2 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen. Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled at two sites. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
DNA.HIVA and MVA.HIVA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
2 sitesin 2 countries
Study dates
Apr 2003to May 2005
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males and females;
  • Age at least 18 years on the day of screening and no greater than 60 years on the day of enrolment;
  • Available for follow up for the planned duration of the study (screening plus 18 months);
  • Able to give written informed consent;
  • Does not engage in risk behaviour as defined by the protocol, willing to undergo HIV testing and receive results;
  • If sexually active female, using an effective method of contraception (combined oral contraceptive pill; injectable contraceptive; IUCD; condoms; anatomical sterility in self or partner) from screening until at least 4 months after last vaccination and willing to undergo urine pregnancy tests at screening and prior to each vaccination and 4 months after the last vaccination;
  • If sexually active male, willing to use an effective method of contraception (such as condoms) from screening until 4 months after the last vaccination.

Who cannot join

  • Clinically relevant abnormality on history or examination including history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the designated trial physician in last 6 months;
  • Presence of any chronic condition;
  • Any of the following abnormal laboratory parameters that are moderate, severe, or very severe: haematology (haemoglobin, absolute neutrophil count absolute lymphocyte count , absolute CD4 count, platelets); urinalysis, biochemistries (total bilirubin, creatinine, AST, ALT). Volunteers with mild laboratory abnormalities which are judged by the principal investigator or designee to be not clinically significant may be enrolled.
  • If female, pregnant or planning a pregnancy within 4 months after last vaccination or lactating;
  • Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment;
  • Receipt of blood transfusion or blood products 6 months prior to enrolment;
Show all 12Show fewer
  • Participation in another clinical trial of an investigational product currently or within last 12 weeks or expected participation during this study;
  • History of severe local or general reaction to vaccination or history of allergic reactions;
  • History of grand-mal epilepsy, or currently taking anti-epileptics;
  • Confirmed HIV-1 or HIV-2 seropositive;
  • Positive for hepatitis B (surface antigen) or confirmed diagnosis of active syphilis at the time of enrolment (RPR positive and TPHA positive or equivalent), positive for hepatitis C antibodies;
  • Unlikely to comply with protocol. Prior receipt of smallpox vaccination should be documented, but will not be an exclusion criterion.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Kenya1 site

  • KAVI (Kenya AIDS Vaccine Initiative)

    Nairobi

Other trials in Kenya

United Kingdom1 site

  • Guys and St. Thomas' Hospital

    London

Other trials in United Kingdom

About this study

Official title: A Randomized, Placebo-Controlled, Dosage-Escalating Phase 2A Study, Double-Blinded With Respect to Assignment to Either Vaccine or Placebo, to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Administered Intramuscularly Followed by an MVA HIV-1 Vaccine Administered at Three Different Dosage Levels and by Three Different Routes to HIV-Uninfected, Healthy, Volunteers.

The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen.

Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment of up to 10% (approximately 10 additional volunteers) will be permitted in the study.

Conditions
HIV Infections
Being tested
DNA.HIVA, MVA.HIVA
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.

  • DNA.HIVABiological

    0.5mg DNA.HIVA or placebo

  • MVA.HIVABiological

    5x10^6 pfu MVA or placebo

  • MVA.HIVABiological

    5x10^7 pfu MVA or placebo

  • MVA.HIVABiological

    2.5x10^8 pfu MVA or placebo

Study groups in NCT01371175
Study groupRoleWhat they receive
Group AExperimentalDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered subcutaneously. Vaccine:Placebo =12/3
Receives: Biological: DNA.HIVA; Biological: MVA.HIVA
Group BExperimentalDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered intramuscularly. Vaccine:Placebo =12/3
Receives: Biological: DNA.HIVA; Biological: MVA.HIVA
Group CExperimentalDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered intradermally. Vaccine:Placebo =18/3
Receives: Biological: DNA.HIVA; Biological: MVA.HIVA
Group DExperimentalDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered subcutaneously. Vaccine:Placebo =12/3
Receives: Biological: DNA.HIVA; Biological: MVA.HIVA
Group EExperimentalDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered intramuscularly. Vaccine:Placebo =12/3
Receives: Biological: DNA.HIVA; Biological: MVA.HIVA
Group FExperimentalDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered subcutaneously. Vaccine:Placebo =12/3
Receives: Biological: DNA.HIVA; Biological: MVA.HIVA
Group GExperimentalDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and 8 delivered intramuscularly. Vaccine:Placebo =12/3
Receives: Biological: DNA.HIVA
Groups C2/D2/E2 (Subgroups of C,D,E)ExperimentalDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and Month 12+ (volunteers offered second MVA/placebo more than 12 months (late boost) after their enrollment into their original treatment assignment) delivered ID, SC, or IM according to original randomization. Vaccine:Placebo = blinded ratio, maximum in C2/D2/E2 = 16.
Receives: Biological: DNA.HIVA; Biological: MVA.HIVA
Group F2/G2 (Subgroup of F and G)ExperimentalDNA or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and Month 12+ (volunteers offered second MVA/placebo more than 12 months (late boost) after their enrollment into their original treatment assignment) delivered either SC or IM according to original randomization. Vaccine:Placebo = blinded ratio, maximum in F/G= 29.
Receives: Biological: DNA.HIVA; Biological: MVA.HIVA

What is being measured

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

  1. Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)

    Measured: 18 months

Secondary outcomes (1)

  1. Immunogenicity: Proportion of volunteers with HIV-1 specific T-cell responses by ELISPOT assay.

    Measured: Day 0, Month 1, Month 2, Month 5, Month 6, Month 8, Month 9, Month 12, Month 18

Timeline

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

  1. First posted10 Jun 2011 (estimated)
  2. Study startApr 2003
  3. Primary completionMay 2005

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
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01371175
Sponsor's protocol ID
IAVI 010
Status last verified
Jun 2011
First submitted
31 May 2011
Last updated
10 Jun 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DNA.HIVA and MVA.HIVA in people with HIV Infections, run by International AIDS Vaccine Initiative at 2 sites in 2 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 12 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 10 Jun 2011. 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 Kenya, United Kingdom. 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 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 (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events) (time frame: 18 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 NCT01371175.

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 10 Jun 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in