| Stage | Type of Clinical Trial | Sponsor |
| 1. Phase 1 -1999 | subunit gp220/350 | Aviron, SmithKline Beecham |
| 2. Phase 1 -1999 | subunit EBNA-3A | Queensland Institute of Medical Research |
| 3. Phase 1 -1995 (completed) | vaccina vector/gp220/350 | [Gu et. al.] China |
Description of trials (same text as within vaccine strategies):
1. A phase I clinical trial conducted by Aviron (1999) demonstrated safety and immunogenicity for a subunit vaccine containing the gp220/350 surface glycoprotein. The proprietary adjuvant was supplied by SmithKline Beecham. The trial was a randomized, double-blind study, containing 67 healthy adult participants. The study indicated that the vaccine was tolerated and safe. Evidence of an immune response was shown by laboratory tests from participant sera (2).
2.The Queenland Institute of Medical Research has conducted a phase I trial designed to test the safety and immunogenicity of an Epstein-Barr virus cytotoxic T cell epitope vaccine. The synthetic peptide, FLRGRAYGL (an HLA B8 restricted epitope from EBNA-3A), is in an emulsion of tetanus toxoid, water, and oil adjuvant Montanide ISA 720. Healthy volunteers who are EBV negative and who are HLA B8 positive have shown no adverse reactions to date (7).
3. A phase
I clinical trial of the recombinant vaccina virus mentioned above has been
successful in China. The trial was performed in three distinct human
populations: EBV-positive adults exposed to the vaccina virus, EBV-positive
children not exposed to the vaccina virus, and EBV-negative infants not
exposed to the vaccina virus. No significant antibody variations
were observed in the adults but EBV-neutralizing titers increased in the
vaccinated children, while antibodies to the viral capsid antigen remained
the same. All vaccinated infants developed MA antibodies with neutralizing
properties in vitro (8).