A Phase I Study to Assess the Safety and Immunogenicity of ChAd63 ME-TRAP - MVA ME-TRAP Heterologous Prime-boost Vaccination Co-administered With EPI Vaccines in Gambian Infants

Malaria Clinical Trial

— VAC058  

Official title:

A Phase I Study to Assess the Safety and Immunogenicity of ChAd63 ME-TRAP - MVA ME-TRAP Heterologous Prime-boost Vaccination Co-administered With EPI Vaccines in Gambian Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083887
• Other study ID #: VAC058
• Status: Completed
• Phase: Phase 1
• First received: February 28, 2014
• Last updated: December 2, 2015
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gambia: Department of State for Health and Social WelfareGambia: MRC Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Two vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, are being tested to see if they will form a safe and effective vaccination strategy against malaria. The vaccines have been found to be well tolerated when tested in Gambian adults, young children and infants, who are at risk of severe malaria. Both vaccines will be given to participating infants at the same time as some EPI (Expanded Program on Immunization) vaccines, and assess whether they are safe and still helpful in making the body's defense system respond.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Weeks

Eligibility

Inclusion Criteria:

• Group 1: 15 healthy infants aged 16 weeks at the time of enrolment with signed consent obtained from parents

• Group 2: 15 healthy infants aged 8 weeks at the time of enrolment with signed consent obtained from parents

• Group 3: 15 healthy infants aged 1 week at the time of enrolment with signed consent obtained from parents

• Group 4 (control): 20 healthy infants aged 16, 8 and 1 weeks at the time of enrolment with signed consent obtained from parents

• Groups 1 and 2: Receipt of all EPI vaccines according to schedule defined as follows:

Bacillus Calmette-Guérin (BCG), and first dose of oral polio (OPV) and Hepatitis B vaccine within 2 weeks of birth; Penta, pneumococcal vaccine, OPV, rotavirus vaccine for Group 1 at 8 weeks +/- 2 weeks

Exclusion Criteria:

• Birth weight less than 2.5kg

• Significant antenatal, perinatal or early postnatal complications as judged by the PI or other delegated individual

• Any signs of acute illness as judged by the PI or other delegated individual

• Axillary temperature of greater than 37.5 °C

• Clinically significant congenital abnormalities as judged by the PI or other delegated individual

• Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.

• Weight for age z-scores below 2 standard deviations of normal for age

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.

• History of splenectomy

• Haemoglobin less than 10 g/dL at > 4 weeks of age or less than 13.0 g/dl at < 4 weeks of age.

• White cell count <5.0 x 109/L

• Serum Creatinine concentration greater than 60 micromol/L,

• Serum alanine aminotransferase (ALT) concentration greater than 45 U/L,

• Clinically significant jaundice

• Any other clinically significant laboratory abnormality as judged by the PI or other delegated individual

• Blood transfusion within one month of enrolment.

• History of vaccination with previous experimental malaria vaccines.

• Administration of any immunoglobulin less than two weeks before vaccination with the IMPs

• Current participation in another clinical trial, or within 12 weeks of this study.

• Any other finding which in the opinion of the PI or other delegated individual would increase the risk of an adverse outcome from participation in the trial.

• Likelihood of travel away from the study area

• Maternal HIV infection (a negative maternal HIV test will be required prior to study enrolment)

• Positive malaria antigen test at screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Biological:
• ChAd63 ME-TRAP / MVA ME-TRAP
Intramuscular administration of ChAd63 ME-TRAP 5 x 10^10 vp and MVA ME-TRAP 1 x 10^8 pfu

Locations

Country	Name	City	State
Gambia	Medical Research Council Unit, Fajara	Banjul

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Malaria Vectored Vaccines Consortium

Country where clinical trial is conducted

Gambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines	Recording of all solicited and unsolicited local and systemic adverse events (including laboratory abnormalities considered adverse events) and the assessment of their causal relationships to the investigative medicinal products (IMPs).	Participants will be followed for the duration of the study, an expected average of 36 weeks	Yes
Secondary	Immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines.		Participants will be followed for the duration of the study, an expected average of 36 weeks	No