Table 2.
Reactogenicity to Synthetic Immunogens in All Vaccinated Volunteers
| Trial B |
Trial A |
||||||||||||
| AE | PADRE-CMV + PF03512676 (n = 19) |
Tet-CMV + PF03512676 (n = 13) |
PADRE-CMV (n = 19) |
Tet-CMV (n = 12) |
Total Vaccinated (N = 63) | ||||||||
| AE gradea | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | % Total |
| Local | |||||||||||||
| Pain | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 8 |
| Pruritus | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Erythema | 0 | 1 | 0 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 8 |
| Allergic reaction | 2 | 2 | 1 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 1 | 17 |
| Systemic | |||||||||||||
| Malaise | 7 | 3 | 1 | 2 | 0 | 1 | 3 | 1 | 0 | 3 | 1 | 0 | 35 |
| Fever | 2 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 13 |
| Chills | 4 | 1 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 14 |
| Myalgia | 2 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 14 |
| Arthralgia | 3 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 10 |
| Nausea | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| Vomiting | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| Headache | 0 | 2 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 11 |
Abbreviations: AE, adverse event; CMV, cytomegalovirus.
AEs are listed according to the HIV Vaccine Trials Network [HVTN]/Division of AIDS intensity grading scale: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening. The table shows the number of volunteers who experienced grade 1, 2, or 3 local or systemic AEs (listed according to the HTVN intensity grading scale) for each vaccine cohort. No toxicity grade 4 AEs were reported. The rightmost column shows the percentages of the postvaccination-related AEs in the total vaccinated population (including 5 withdrawn volunteers). AEs that were considered unrelated or unlikely to be related to the investigational agent are not provided.