HIV-1Phase 1/2PedVacc002NCT00981695
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected Mothers
A Phase 1/2 study testing MVA.HIVA in people with HIV-1 and HIV Infections, run by Medical Research Council at 1 site in Kenya.
Trial summary
Objectives: Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers. Secondary: HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control arms in each cohort (breastfeeding or formula feeding) HIV-1 immunogenicity… Read more about this study
- Who is it for?
- Ages Up to 3 days
- Conditions the study is for
- HIV-1, HIV Infections
- What is being tested?
- MVA.HIVA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteKenya
- Study dates
- Nov 2009to Oct 2011
- Phase
- Phase 1/2
- 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 Up to 3 days
- All sexes
- No healthy volunteers
- Child
Infant Inclusion Criteria
- Healthy infants
- < 3 days of age (day of birth = Day 0) at enrolment
- Birth weight > 2500 grams
- Born to an eligible woman
- Written informed consent by parent
Infant Exclusion Criteria
- HIV infection, as determined by a filter paper and/or RNA test prior to vaccination.
- Participation in any other HIV-1 vaccine or drug trial.
- Failure to receive all standard KEPI immunizations according to national immunization programme.
- Weight for age z-scores outside of 2 standard deviations of normal at the time of vaccination.
- 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., 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 by the time of vaccination.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
Kenya1 site, 1 recruiting
- Recruiting
Kenyatta National Hospital
Nairobi
Walter Jaoko
About this study
Official title: An Open Randomized Phase I/II Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1-infected Mothers
Objectives:
Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers.
Read more
Secondary:
- HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control arms in each cohort (breastfeeding or formula feeding)
- HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants receiving MVA.HIVA
- HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants in the age-matched unvaccinated control group
- Comparison of responses to certain Kenyan Extended Programme on Immunization (KEPI) vaccines (OPV, DTP, HBV, and HiB) between MVA.HIVA versus age-matched unvaccinated controls in each cohort, between breast versus formula feeding infants in the age-matched unvaccinated control group, and between breast versus formula infants receiving MVA.HIVA
- Comparison of immune activation and phenotypic profile of lymphocytes between breast and formula feeding infants in each cohort (MVA.HIVA and age-matched unvaccinated control)
- Build capacity for Infant HIV-1 Vaccine Clinical Trials Centre in Nairobi, Kenya.
- Conditions
- HIV-1, HIV Infections
- Being tested
- MVA.HIVA
- Keywords
- HIV, Vaccine, MVA, PMTCT, HIV preventive vaccine, HIV seronegativity
- 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 | 18 breast-fed and 18 formula-fed infants at the age of 20 weeks Receives: Biological: MVA.HIVA |
| Controls | No intervention | 18 breast-fed and 18 formula-fed infants at the age of 20 weeks |
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 28 weeks after vaccination
Secondary outcomes (2)
For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA.
Measured: 1 week before and 1 week after vaccination
For immunogenicity to MVA.HIVA: Frequency of IFN-γ-producing cells determined in an ELISPOT assay after overnight stimulation with a pool of HIVA-derived peptides.
Measured: Up to 24 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 posted22 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2011 (estimated)
- Study completionOct 2011 (estimated)
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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
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 CouncilWalter Jaoko, Principal investigator, University of NairobiGrace John-Stewart, Principal investigator, University of WashingtonMarie Reilly, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981695
- Sponsor's protocol ID
- PV002
- Acronym
- PedVacc002
- Status last verified
- Sep 2009
- First submitted
- 21 Sep 2009
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Njuguna IN, Ambler G, Reilly M, Ondondo B, Kanyugo M, Lohman-Payne B, Gichuhi C, Borthwick N, Black A, Mehedi SR, Sun J, Maleche-Obimbo E, Chohan B, John-Stewart GC, Jaoko W, Hanke T. PedVacc 002: a phase I/II randomized clinical trial of MVA.HIVA vaccine administered to infants born to human immunodeficiency virus type 1-positive mothers in Nairobi. Vaccine. 2014 Oct 7;32(44):5801-8. doi: 10.1016/j.vaccine.2014.08.034. Epub 2014 Aug 27.
PubMed 25173484
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomized Phase I/II Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1-infected Mothers
- ClinicalTrials.gov ID
- NCT00981695
- Acronym / sponsor ID
- PedVacc002 / PV002
- Conditions
- HIV-1, HIV Infections
- Keywords
- HIV, Vaccine, MVA, PMTCT, HIV preventive vaccine, HIV seronegativity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- Nov 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 22 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:
Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers.
Secondary:
- HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control arms in each cohort (breastfeeding or formula feeding)
- HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants receiving MVA.HIVA
- HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants in the age-matched unvaccinated control group
- Comparison of responses to certain Kenyan Extended Programme on Immunization (KEPI) vaccines (OPV, DTP, HBV, and HiB) between MVA.HIVA versus age-matched unvaccinated controls in each cohort, between breast versus formula feeding infants in the age-matched unvaccinated control group, and between breast versus formula infants receiving MVA.HIVA
- Comparison of immune activation and phenotypic profile of lymphocytes between breast and formula feeding infants in each cohort (MVA.HIVA and age-matched unvaccinated control)
- Build capacity for Infant HIV-1 Vaccine Clinical Trials Centre in Nairobi, Kenya.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinees | Experimental | Biological: MVA.HIVA18 breast-fed and 18 formula-fed infants at the age of 20 weeks |
| Controls | No intervention | –18 breast-fed and 18 formula-fed infants at the age of 20 weeks |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 28 weeks after vaccination
2 secondary outcomes
For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA.
Time frame: 1 week before and 1 week after vaccination
For immunogenicity to MVA.HIVA: Frequency of IFN-γ-producing cells determined in an ELISPOT assay after overnight stimulation with a pool of HIVA-derived peptides.
Time frame: Up to 24 weeks after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
- Derived from this study: PubMed 25173484Njuguna IN, Ambler G, Reilly M, Ondondo B, Kanyugo M, Lohman-Payne B, Gichuhi C, Borthwick N, Black A, Mehedi SR, Sun J, Maleche-Obimbo E, Chohan B, John-Stewart GC, Jaoko W, Hanke T. PedVacc 002: a phase I/II randomized clinical trial of MVA.HIVA vaccine administered to infants born to human immunodeficiency virus type 1-positive mothers in Nairobi. Vaccine. 2014 Oct 7;32(44):5801-8. doi: 10.1016/j.vaccine.2014.08.034. Epub 2014 Aug 27.
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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
Walter Jaoko principal investigator
University of Nairobi
Grace John-Stewart principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MVA.HIVA in people with HIV-1 and HIV Infections, run by Medical Research Council at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 16 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 1 site in Kenya. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walter Jaoko, MB MTMed PhD (+254-02-2717694, Wjaoko@kaviuon.org), or a site near the patient. 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 28 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 NCT00981695, 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 16 Jun 2011.