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Effect of adjuvant on reactogenicity and long-term immunogenicity of the malaria Vaccine ICC-1132 in macaques
Jan A M Langermans1, Annette Schmidt, Richard A W Vervenne
1Department of Parasitology, Biomedical Primate Research Centre, 2280 GH Rijswijk, The Netherlands.
Abstract:
ICC-1132 is a malaria vaccine candidate based on a modified hepatitis B virus core particle (HBc) bearing putative protective epitopes from the circumsporozoite protein (CS) of Plasmodium falciparum. While the epitope carrier itself is immunogenic, its potency can be increased by formulation with adjuvants. As a prelude to Phase I clinical trials, rhesus macaques were immunised twice with GMP grade ICC--1132 in saline or formulated with the adjuvants Alhydrogel (Alhydrogel) or Montanide((R)) ISA 720 (Montanide). Both adjuvant formulations gave significant humoral responses after the first injection, with titres increasing further after the second dose. The Montanide formulation was the most immunogenic, but undesirable reactogenicity in the form of sterile abscesses was associated with higher dosage levels of ICC--1132. These side effects could be avoided with lower antigen load, or by formulation of the second dose in Alhydrogel. Such measures also reduced peak titres and longevity of antibodies against CS, demonstrating the delicate balance between immunogenicity and reactogenicity of new vaccine formulations.
Insights
This study evaluated ICC-1132, a malaria vaccine candidate, with adjuvants in macaques. Montanide enhanced immune response but caused side effects, while Alhydrogel offered a safer alternative, highlighting a balance between immunogenicity and reactogenicity.
Area of Science:
- Vaccinology
- Immunology
- Parasitology
Background:
- ICC-1132 is a malaria vaccine candidate using a hepatitis B virus core particle (HBc) displaying Plasmodium falciparum circumsporozoite protein (CS) epitopes.
- Adjuvants can enhance the immunogenicity of vaccine candidates like ICC-1132.
Purpose of the Study:
- To assess the immunogenicity and reactogenicity of ICC-1132 formulated with Alhydrogel or Montanide adjuvants in rhesus macaques.
- To inform formulation strategies for upcoming Phase I clinical trials.
Main Methods:
- Rhesus macaques were immunized twice with GMP-grade ICC-1132, either alone, with Alhydrogel, or with Montanide.
- Humoral responses (antibody titers) and reactogenicity (adverse effects) were monitored after each immunization.
Main Results:
- Both Alhydrogel and Montanide formulations induced significant humoral responses after the first dose, which increased after the second.
- The Montanide formulation showed higher immunogenicity but was associated with sterile abscesses at higher antigen doses.
- Reducing antigen load or using Alhydrogel for the second dose mitigated reactogenicity but also reduced antibody titers and longevity.
Conclusions:
- Adjuvant selection and dosage are critical for balancing the immunogenicity and reactogenicity of the ICC-1132 malaria vaccine candidate.
- Montanide ISA 720 is highly immunogenic but requires careful dose management to avoid adverse effects.
- Alhydrogel presents a potentially safer alternative, though with a possible trade-off in peak antibody response and duration.
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