NCT00981695

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 16, 2011

Status Verified

September 1, 2009

Enrollment Period

1.7 years

First QC Date

September 21, 2009

Last Update Submit

June 15, 2011

Conditions

HIV-1HIV Infections

Keywords

HIVVaccineMVAPMTCTHIV preventive vaccineHIV seronegativity

Outcome Measures

Primary Outcomes (1)

  • For safety and reactogenicity: Actively and passively collected data on adverse events.

    Up to 28 weeks after vaccination

Secondary Outcomes (2)

  • For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA.

    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.

    Up to 24 weeks after vaccination

Study Arms (2)

Vaccinees

EXPERIMENTAL

18 breast-fed and 18 formula-fed infants at the age of 20 weeks

Biological: MVA.HIVA

Controls

NO INTERVENTION

18 breast-fed and 18 formula-fed infants at the age of 20 weeks

Interventions

MVA.HIVABIOLOGICAL

1 dose of 5 x 10\^7 pfu of MVA.HIVA administered intramuscularly

Vaccinees

Eligibility Criteria

AgeUp to 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kenyatta National Hospital

Nairobi, Kenya

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25173484DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Tomas Hanke

    Medical Research Council

    STUDY DIRECTOR

  • Walter Jaoko

    University of Nairobi

    PRINCIPAL INVESTIGATOR

  • Grace John-Stewart

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Marie Reilly

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter Jaoko, MB MTMed PhD

CONTACT

+254-02-2717694Wjaoko@kaviuon.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

November 1, 2009

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

June 16, 2011

Record last verified: 2009-09

Locations

KE(1)