HIV-1Phase 1PedVacc001NCT00982579
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers
A Phase 1 study testing MVA.HIVA in people with HIV-1 and HIV Infections, run by Medical Research Council at 1 site in The Gambia.
Trial summary
Objectives: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers. Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG… Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- HIV-1, HIV Infections
- What is being tested?
- MVA.HIVA
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteThe Gambia
- Study dates
- Nov 2009to Sep 2011
- 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 Up to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants, 19 weeks of age, with weight for age z-scores within 2 standard deviations of normal.
- Have received all standard EPI immunizations according to national immunization programme.
- Written informed consent by parent.
- Mother HIV-1/2-uninfected.
Who cannot join
- Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory tract infection with or without low-grade febrile illness, i.e. axillary temperature of <37.5 °C ).
- Axillary temperature of ≥ 37.5 °C at the time of vaccination.
- Any clinically significant abnormal finding on screening from biochemistry or haematology at 19 weeks.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products.
- Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine.
- Invasive bacterial infections (pneumonia, meningitis).
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- Any other on-going chronic illness requiring hospital specialist supervision.
- Administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate.
- Any history of anaphylaxis in reaction to vaccination.
- Research physician's assessment of lack of willingness by parents to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the infant's risk of suffering an adverse outcome.
- Likelihood of travel away from the study area.
- Untreated malaria infection.
- Any other clinical evidence of infection.
Trial locations and contacts
1 site in 1 country.
The Gambia1 site
Medical Research Council Laboratories, The Gambia
Banjul, Fajara
About this study
Official title: An Open Randomized Phase I Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1/2-uninfected Mothers
Objectives:
Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers.
Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.
- Conditions
- HIV-1, HIV Infections
- Being tested
- MVA.HIVA
- Keywords
- HIV preventive 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.
MVA.HIVABiological
1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Vaccinees | Experimental | Vaccinated at 20 weeks of age (n=24) Receives: Biological: MVA.HIVA |
| Controls | No intervention | No experimental vaccine (n=24) |
What is being measured
The primary outcome is the main question the study is designed to answer.
For safety and reactogenicity: Actively and passively collected data on adverse events
Measured: Up to 16 weeks after vaccination
Secondary outcomes (2)
For immunity to EPI vaccines: Antibody levels to specific vaccines.
Measured: 1 week before and 1 week after vaccination
For immunogenicity: Frequency of IFN-γ producing cells determined in ex-vivo (effector) and 10-day cultured (memory) ELISPOT assays after overnight stimulation with pools of HIVA-derived peptides
Measured: Up to 16 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Investigators
- Tomas Hanke, Study director, Medical Research CouncilKatie Flanagan, Principal investigator, Medical Research Council, The GambiaMarie Reilly, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982579
- Sponsor's protocol ID
- PV001
- Acronym
- PedVacc001
- Status last verified
- Sep 2009
- First submitted
- 22 Sep 2009
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Afolabi MO, Ndure J, Drammeh A, Darboe F, Mehedi SR, Rowland-Jones SL, Borthwick N, Black A, Ambler G, John-Stewart GC, Reilly M, Hanke T, Flanagan KL. A phase I randomized clinical trial of candidate human immunodeficiency virus type 1 vaccine MVA.HIVA administered to Gambian infants. PLoS One. 2013 Oct 24;8(10):e78289. doi: 10.1371/journal.pone.0078289. eCollection 2013.
PubMed 24205185
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomized Phase I Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1/2-uninfected Mothers
- ClinicalTrials.gov ID
- NCT00982579
- Acronym / sponsor ID
- PedVacc001 / PV001
- Conditions
- HIV-1, HIV Infections
- Keywords
- HIV preventive vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical Research CouncilOther government
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers.
Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinees | Experimental | Biological: MVA.HIVAVaccinated at 20 weeks of age (n=24) |
| Controls | No intervention | –No experimental vaccine (n=24) |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy infants, 19 weeks of age, with weight for age z-scores within 2 standard deviations of normal.
- Have received all standard EPI immunizations according to national immunization programme.
- Written informed consent by parent.
- Mother HIV-1/2-uninfected.
Key exclusion criteria (13 listed)
- Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory tract infection with or without low-grade febrile illness, i.e. axillary temperature of <37.5 °C ).
- Axillary temperature of ≥ 37.5 °C at the time of vaccination.
- Any clinically significant abnormal finding on screening from biochemistry or haematology at 19 weeks.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products.
- Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA.HIVA1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly | Biological | Vaccinees |
Primary outcome
For safety and reactogenicity: Actively and passively collected data on adverse events
Time frame: Up to 16 weeks after vaccination
2 secondary outcomes
For immunity to EPI vaccines: Antibody levels to specific vaccines.
Time frame: 1 week before and 1 week after vaccination
For immunogenicity: Frequency of IFN-γ producing cells determined in ex-vivo (effector) and 10-day cultured (memory) ELISPOT assays after overnight stimulation with pools of HIVA-derived peptides
Time frame: Up to 16 weeks after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
- Derived from this study: PubMed 24205185Afolabi MO, Ndure J, Drammeh A, Darboe F, Mehedi SR, Rowland-Jones SL, Borthwick N, Black A, Ambler G, John-Stewart GC, Reilly M, Hanke T, Flanagan KL. A phase I randomized clinical trial of candidate human immunodeficiency virus type 1 vaccine MVA.HIVA administered to Gambian infants. PLoS One. 2013 Oct 24;8(10):e78289. doi: 10.1371/journal.pone.0078289. eCollection 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas Hanke study director
Medical Research Council
Katie Flanagan principal investigator
Medical Research Council, The Gambia
Marie Reilly principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVA.HIVA in people with HIV-1 and HIV Infections, run by Medical Research Council at 1 site in The Gambia.
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 4 inclusion and 13 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 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Gambia. 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?
For safety and reactogenicity: Actively and passively collected data on adverse events (time frame: Up to 16 weeks after vaccination). 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 NCT00982579, 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 3 Feb 2012.