Combining Viral Vectored & Protein Adjuvant Malaria Vaccines

• Research type

  Research Study

• Full title

  A Phase Ia Study to Assess the Safety and Immunogenicity of Novel Schedules for Vaccination with the Candidate Malaria Vaccines; AdCh63 AMA1, MVA AMA1 & AMA1-C1/Alhydrogel® +/- CPG 7909

• IRAS ID

  71549

• Contact name

  Adrian VS Hill

• Eudract number

  2010-024166-22

• ISRCTN Number

  n/a

• Research summary

  AdCh63 AMA1, MVA AMA1 and AMA1-C1/Alhydrogel© CPG 7909 are candidate vaccines against the blood-stage of Plasmodium falciparum malaria infection. AdCh63 AMA1 and MVA AMA1 are inactivated viruses which have been modified so that they cannot reproduce in humans. Genetic information has been added to make them express a particular malaria parasite protein; Apical Membrane Antigen 1 (AMA1). AMA1-C1/Alhydrogel© is a malaria vaccine made from the combination of AMA1 protein and the adjuvant Alhydrogel (adjuvants make vaccines more stimulatory to the immune system). Studies have shown that adding CPG 7909 (another adjuvant) to AMA1-C1/Alhydrogel© can further increase the immune response ilicited by the vaccine. These vaccines are designed to stimulate an immune response against AMA1 which protects against malaria infection. In previous research in the UK and in the USA these vaccines have been given separately to healthy adults and have demonstrated promising results in the areas of safety and immunogenicity (ability to induce the desired immune response). However, efficacy (ability to protect people from malaria) has been limited. It is thought that combining viral vectored vaccines with protein vaccines may achieve better immunogenicity and efficacy than the individual vaccines administered separately. This study will therefore evaluate different combinations of AdCh63 AMA1, MVA AMA1 and AMA1-C1/Alhydrogel© CPG 7909, varying the timing and sequence of vaccinations in order to determine which is the most effective. The participants will be followed by health care professionals to gain information about the safety of the vaccine schedules and will undergo blood sampling in order to assess immunogenicity. The study will be conducted at the Clinical Centre for Vaccinology and Tropical Medicine, University of Oxford, UK.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/H0604/2

• Date of REC Opinion

  8 Mar 2011

• REC opinion

  Further Information Favourable Opinion