IARC India HPV vaccine dose study (one, two or three doses)
When an Indian vaccine trial was halted midway, thousands of girls had had only one shot; following them for ten years showed one dose protected as well as three, changing the world's vaccination policy.
Overview
The study began as a randomised comparison of two versus three doses of quadrivalent HPV vaccine at nine Indian centres. Recruitment was suspended in 2010 by the government, leaving by-default cohorts of girls who had received one dose (4,949), two doses (4,980) or three doses (4,348). At a median follow-up of 9.0 years, vaccine efficacy against persistent HPV 16/18 infection was 95.4% (95% CI 85.0-99.9) after one dose, 93.1% (77.3-99.8) after two and 93.3% (77.5-99.7) after three, and one-dose antibody levels, though lower, were stable. With the KEN SHE randomised trial in Kenya, these results led WHO in 2022 to endorse one- or two-dose schedules, roughly halving the cost of protecting a girl.
- 95.4 vs 93.1 out of 100 reached this endpoint with One dose compared with Two doses; 2.3 more per 100.
- Roughly one extra person helped for every 43 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Other groups: Three doses 93.3 of 100.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Girls aged 10-18 in India randomised to two or three doses of quadrivalent HPV vaccine; after a 2010 suspension of recruitment, cohorts who had received one, two or three doses were followed for a decade. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
17,729 participants enrolled.
95% CI 85.0-99.9 · 95% CI 77.3-99.8 · 95% CI 77.5-99.7
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Vaccine efficacy against persistent HPV 16/18 infectionprimary | One dose | 4,949 | 95.4% | — | — | link |
| Two doses | 4,980 | 93.1% | ||||
| Three doses | 4,348 | 93.3% |
Pages like this
not linked directly; found by shared links- CompanySerum Institute of India
Shares CERVAVAC (quadrivalent HPV vaccine, India), Nonavalent HPV vaccine, HPV & HBV vaccination, Prevention we already have is not deployed.
- TrialOsmanabad cervical screening trial (HPV testing vs cytology vs VIA)
Shares Rengaswamy Sankaranarayanan, International Agency for Research on Cancer (IARC / WHO), Tata Memorial Centre, Prevention we already have is not deployed.
- PersonIan Frazer
Shares KEN SHE (single-dose HPV vaccine), Nonavalent HPV vaccine, HPV & HBV vaccination, Prevention we already have is not deployed.
- IdeaEliminate infection-caused cancers: HPV, hepatitis B and C, H. pylori and EBV
Shares International Agency for Research on Cancer (IARC / WHO), HPV & HBV vaccination, Prevention we already have is not deployed, Most of the world has almost no cancer care.
- IdeaSwitch every country to single-dose HPV vaccination and add catch-up to age 26
Shares International Agency for Research on Cancer (IARC / WHO), HPV & HBV vaccination, Prevention we already have is not deployed, Most of the world has almost no cancer care.
- Key paperHPV screening for cervical cancer in rural India (Osmanabad)
Shares Rengaswamy Sankaranarayanan, International Agency for Research on Cancer (IARC / WHO), Tata Memorial Centre, Prevention we already have is not deployed.
- PersonJian Zhou
Shares Nonavalent HPV vaccine, HPV & HBV vaccination, Prevention we already have is not deployed, Cervical cancer.
- TechnologyHPV DNA testing and self-sampling
Shares Partha Basu, Single-dose HPV vaccination plus HPV self-sampling to reach WHO elimination in low-income countries, Rengaswamy Sankaranarayanan, HPV & HBV vaccination.