Table 5.
Efficacy of RTS,S vaccine formulations in field trials
| Location and time period of study | Age of participants | Adjuvant | Time/dose of RTS,S in volume of adjuvant | Follow-up period | Vaccine efficacy according-to-protocol analysis | References | |||
|---|---|---|---|---|---|---|---|---|---|
| Infection | First or only clinical episode | All clinical episodes | Severe malaria | ||||||
|
Gambia 1998 |
18–45 years | AS02 |
0, 1, 5 months 50 µg/0.5 mL |
15 weeks | 34% | NR | 31% | NR | [81] |
| 9 weeks/9–15 weeks | 71%/0% | NR | NR | NR | |||||
| Booster dose at 18 months | 9 weeks | 47% | NR | 59% | NR | ||||
|
Mozambique (Manhica) (Cohort 1) 2003–2007 |
1–4 years | AS02A |
0, 1, 2 months 25 µg/0.25 mL (half of adult dose) |
6.5 months | NR | 29.9% | 27.4% | 57.7% | [83–85] |
| 18.5 months | NR | 35.3% | 29.8% | 48.6% | |||||
| 42.5 months | NR | 30.5% | 25.6% | 38.3% | |||||
|
Mozambique (Ilha Joshua) (Cohort 2) 2003–2005 |
1–4 y | AS02A | 0, 1, 2 months | 6.5 months | 45% | 35.4% | 30% | NR | [83, 86] |
| 25 µg/0.25 mL (half of adult dose) | 12.5 months | NR | 9% | NR | NR | ||||
|
Mozambique (Ilha Joshua and Taninga) 2005–2007 |
1st dose at 10 weeks of age | AS02D |
0, 1, 2 months 25 µg/0.5 mL |
3 months | 65.9% | 65.8% | NR | NR | [88, 89] |
| 11 months | NR | 33% | 25.9% | NR | |||||
|
Kenya 2005–2006 |
18–35 years | AS02A |
0, 1, 2 months 50 µg/0.5 mL |
14 weeks | 35.1% | NR | NR | NR | [92] |
| AS01B |
0, 1, 2 months 50 µg/0.5 mL |
14 weeks | 11% | NR | NR | NR | |||
|
Tanzania 2006–2009 |
1st dose at 8 weeks of age | AS02D |
0, 1, 2 months 25 µg/0.5 mL |
6 months | 65.2% | 58.6% | NR | NR | [90, 132] |
| 12 months | NR | 53.6% | 50.7% | NR | |||||
| 18 months | NR | 34.9% | 26.7% | NR | |||||
|
Kenya and Tanzania 2007–2016 |
5–17 months | AS01E |
0, 1, 2 months 25 µg/0.5 mL |
Mean 7.9 months | NR | 53% | 56% | NR | [93–96] |
| 12 months | NR | 39.2% | 42% | NR | |||||
| 15 months | NR | 45.8% | 51% | NR | |||||
| 4 y | NR | 32.1% | 23.5% | NR | |||||
| 7 y | NR | 33.8% | 7% | NR | |||||
|
Ghana, Tanzania, Gabon 2007–2009 |
6–10 weeks | AS01E |
0, 1, 2 months 25 µg/0.5 mL |
12 months | NR | 61.6% | NR | NR | [97] |
| 17 months | NR | 52.5% | 59.1% | NR | |||||
|
0, 1, 7 months 25 µg/0.5 mL |
12 months | NR | 63.8% | NR | NR | ||||
|
Mozambique, Malawi, Tanzania, Kenya, Burkina Faso, Ghana, Gabon 2009–2014 |
5–17 months | AS01E |
0, 1, 2 months 25 µg/0.5 mL |
12 months | NR | 55.8% | 55.1% | 47.3% | [99–102] |
| 18 months | NR | NR | 45.7% | 35.5% | |||||
| 48 monthsa | NR | NR | 28.3% | 1.1% | |||||
| 6–12 weeks |
0, 1, 2 months 25µg/0.5mL |
12 months | NR | 31.5% | 33% | 36.6% | |||
| 18 months | NR | NR | 26.6% | 14.9% | |||||
| 38 monthsa | NR | NR | 18.3% | 10.3% | |||||
| 5–17 months | Booster dose at month 20 | 48 monthsa | NR | NR | 36.3% | 32.2% | |||
| 6–12 weeks | Booster dose at month 20 | 38 monthsa | NR | NR | 25.9% | 17.3% | |||
NR not reported
aFollow-up period is from Dose 1 (study Day 0). This unadjusted analysis uses a modified intention-to-treat population [102]