NCT00982579

Brief 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 vaccine within the first 4 weeks of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

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 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 3, 2012

Status Verified

September 1, 2009

Enrollment Period

1.6 years

First QC Date

September 22, 2009

Last Update Submit

February 2, 2012

Conditions

HIV-1HIV Infections

Keywords

HIV preventive vaccine

Outcome Measures

Primary Outcomes (1)

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

    Up to 16 weeks after vaccination

Secondary Outcomes (2)

  • For immunity to EPI vaccines: Antibody levels to specific vaccines.

    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

    Up to 16 weeks after vaccination

Study Arms (2)

Vaccinees

EXPERIMENTAL

Vaccinated at 20 weeks of age (n=24)

Biological: MVA.HIVA

Controls

NO INTERVENTION

No experimental vaccine (n=24)

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 VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Council Laboratories, The Gambia

Banjul, Fajara, The Gambia

Location

Related Publications (1)

  • 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.

    PMID: 24205185DERIVED

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

  • Katie Flanagan

    Medical Research Council, The Gambia

    PRINCIPAL INVESTIGATOR

  • Marie Reilly

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 23, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

February 3, 2012

Record last verified: 2009-09

Locations

TH(1)