Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers (PedVacc001)

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV-1
• Intervention / Treatment: Biological: MVA.HIVA

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Gambia
  • Fajara
    • Banjul, Fajara, Gambia
      • Medical Research Council Laboratories, The Gambia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccinees; Vaccinated at 20 weeks of age (n=24)	Biological: MVA.HIVA; 1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly
No Intervention: Controls; No experimental vaccine (n=24)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
For safety and reactogenicity: Actively and passively collected data on adverse events	Up to 16 weeks after vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical Research Council
• Collaborators: European and Developing Countries Clinical Trials Partnership (EDCTP)
• Investigators: Study Director: Tomas Hanke, Medical Research Council; Principal Investigator: Katie Flanagan, Medical Research Council, The Gambia; Principal Investigator: Marie Reilly, Karolinska Institutet

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 22, 2009
• First Submitted That Met QC Criteria: September 22, 2009
• First Posted (Estimate): September 23, 2009

Study Record Updates

• Last Update Posted (Estimate): February 3, 2012
• Last Update Submitted That Met QC Criteria: February 2, 2012
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: HIV preventive vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: PV001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No