. 2022 Aug 3;52:101585. doi: 10.1016/j.eclinm.2022.101585

Table 1.

Summary of the study and participant characteristics of the N_s = 18 independent trials included (Details of the N_p = 43 publications included are presented in Supplement Table S3).

	Single arm trials (Longitudinal studies)		Controlled trials
	Number (N_s = 8)	References (N_p = 22)	Number (N_s = 10)	References (N_p = 21)
A) Study characteristics
*WHO region*
Africa	1	³⁰^,⁴⁸	1	⁴⁹^,⁵⁰
America	4	³²^,⁴⁶^,⁴⁷^,51, 52, 53^,⁵⁴^,⁵⁵^,⁵⁶^,75, 76, 77, 78, 79	4	⁶²^,⁶³^,⁶⁴^,⁶⁵^,⁶⁶^,⁶⁷^,⁶⁸^,⁶⁹
Europe	1	⁷⁰	4	³¹^,⁷¹^,83, 84, 85, 86, 87, 88, 89
Asia	1	⁷⁹^,⁸⁰	0	−
Mix	1	⁸¹^,⁸²^,⁸³	1	⁸⁴^,⁸⁵
*Study year (mid-point)*
2000-2010	3	³⁰^,³²^,⁴⁷^,⁵²^,⁵³^,⁷⁹^,⁵⁶^,⁵⁷^,77, 78, 79	2	⁶²^,⁶⁶^,⁴⁹^,⁶⁹
Post 2010	4	⁴⁶^,⁵¹^,⁵⁴^,⁵⁵^,⁴⁸^,⁵⁸^,⁶⁹^,⁸⁰	8	³¹^,⁶³^,⁷¹^,⁶⁴^,⁶⁵^,⁶⁷^,⁶⁸^,83, 84, 85, 86, 87, 88, 89^,⁸⁴^,⁸⁵
Not reported	1	⁷⁰	0	−
*Vaccine type*
Nonavalent	0	−	1	⁷⁷^,⁷⁸
Quadrivalent	8	³⁰^,³²^,46, 47, 48, 49^,51, 52, 53^,⁵⁴^,58, 60, 59^,⁴⁸^,75, 76, 77, 78, 79^,⁷⁰^,⁸⁰^,⁸³	7	³¹^,⁶²^,⁶³^,⁷¹^,⁶⁴^,⁶⁵^,⁶⁶^,⁶⁷^,⁶⁹^,83, 84, 85, 86, 87^,⁸⁴^,⁸⁵
Bivalent	0	−	4	³¹^,⁴⁹^,⁵⁰^,⁶⁸^,⁷²^,⁷³^,⁷⁶^,⁸⁴^,⁸⁵
*Vaccine doses*
3 doses	8	³¹^,⁴⁶^,⁴⁷^,⁶²^,⁶³^,⁶⁴^,⁷⁹^,⁶⁵^,⁶⁶^,⁶⁷^,72, 73, 74^,⁵⁹^,⁶⁸^,⁶⁹^,83, 84, 85, 86, 87	10	³²^,⁸¹^,⁵²^,⁵³^,⁵⁶^,⁶⁰^,⁷⁷^,⁷⁸^,⁸⁴^,⁸⁵
4 doses	1	⁵⁷^,⁶⁰	2	⁶³^,⁶⁶^,⁶⁷^,⁶⁹
*Study design*
Randomized controlled trials:	N/A	−	7	³¹^,⁶²^,⁶³^,⁷¹^,⁶⁴^,⁶⁵^,⁶⁶^,⁶⁷^,⁴⁹^,⁵⁰^,⁶⁹^,83, 84, 85^,⁷⁶^,⁸⁴^,⁸⁵
Quadrivalent vaccine vs Placebo	N/A	−	4	⁶²^,⁶³^,⁷¹^,⁶⁴^,⁶⁵^,⁶⁶^,⁶⁷^,⁶⁹^,⁷⁴
Bivalent vaccine vs Placebo	N/A	−	1	⁴⁹^,⁵⁰
Quadrivalent vs Bivalent vaccines	N/A	−	2	³¹^,⁷²^,⁷³^,⁷⁶^,⁸⁴^,⁸⁵
Three vs four doses of quadrivalent vaccine	N/A		2	⁶³^,⁶⁶^,⁶⁷
Non randomized controlled trials:⁺	N/A	−	3	⁶⁸^,⁷⁵^,⁷⁷^,⁷⁸
Trials with historical controls (HIV positive unvaccinated, HIV negative vaccinated or HIV negative unvaccinated)	5	³⁰^,⁵¹^,⁵²^,⁵⁴^,⁵⁵^,⁴⁸^,⁶¹	2	⁶²^,⁶³
*Number of trial participants (at entry)*
Median across studies (IQR)	150 (99-307)		97 (91–219)
Follow-up duration
<1 year	3	⁶²^,⁶⁸^,⁷⁴	4	³⁰^,⁸²^,⁵¹^,⁵⁴^,⁵⁵^,⁵⁷^,⁶¹^,⁶⁹^,⁷⁰^,88, 89, 90
1-2 years	6	³¹^,⁴⁶^,⁷⁹^,⁴⁹^,⁵⁰^,⁵⁹^,⁷²^,⁷³^,⁷⁵^,⁷⁶	2	⁵⁸^,⁸⁴^,⁸⁵
>2 years (maximum: 8 years)	3	⁴⁷^,⁶³^,⁶⁴^,⁶⁵^,⁶⁶^,⁶⁷^,⁴⁸^,⁶⁹	4	⁸¹^,⁸²^,51, 52, 53^,⁵⁴^,⁷¹^,⁵⁵^,⁵⁶^,⁵⁸^,⁶⁹^,⁸⁰
B) Participant characteristics
*Sex*
Female	5	47, 48, 49^,51, 52, 53^,⁵⁴^,58, 60, 59^,⁵⁸^,⁵⁹^,⁷⁰^,⁸⁰^,⁸³	2	⁴⁹^,⁵⁰^,⁸⁴^,⁸⁵
Male	2	³²^,⁴⁶^,⁵⁷^,⁶⁰^,⁶¹	2	⁷¹^,⁶⁸^,⁷⁴
Female and Male	1	³⁰^,⁴⁸	6	³¹^,⁶²^,⁶³^,⁶⁴^,⁶⁵^,⁶⁶^,⁶⁷^,⁶⁹^,⁷²^,⁷³^,86, 87, 88, 89
*Age category*^/
Children (≤18 years)^♯	3	³⁰^,⁵⁴^,⁴⁸^,⁷⁰	2	⁶²^,⁶³^,⁶⁶^,⁶⁷^,⁶⁹
Adults (>18 years)	3	³²^,⁴⁶^,⁵¹^,⁵⁷^,77, 78, 79	6	³¹^,⁷¹^,⁶⁴^,⁶⁵^,⁴⁹^,⁵⁰^,⁶⁸^,83, 84, 85^,87, 88, 89
Mix of adults and children	4	47, 48, 49^,⁵²^,⁵³^,58, 60, 59^,⁵⁸^,⁸⁰^,⁸³	2	⁷⁵^,⁸⁴^,⁸⁵
*Proportion of participants on ART (Baseline)*
100%	1	⁷⁰	1	⁷⁶
67-99%	3	³⁰^,³²^,⁵⁴^,⁵⁵^,⁴⁸^,⁶⁰^,⁶¹	6	³¹^,⁶³^,⁷¹^,⁶⁴^,⁶⁶^,⁶⁷^,83, 84, 85^,⁷⁷
25-66%	2	⁸¹^,⁵²^,⁵³^,⁷⁹^,⁵⁶^,⁸³	1	⁸⁵
<25%	0	−	1	⁵⁰
Not reported	5	⁴⁶^,⁴⁷^,⁸²^,⁵¹^,75, 76, 77^,⁸⁰	7	⁶²^,⁶⁵^,⁴⁹^,⁶⁸^,⁶⁹^,⁷⁵^,⁷⁸^,⁸⁴
*Baseline CD4 count (Mean or Median)*
<350 cells/mm³	1	⁸¹^,⁸²^,⁸³	0	−
350–500 cells/mm³	1	⁴⁷	1	⁵⁰
>500 cells/mm³	4	³⁰^,³²^,⁵¹^,⁵²^,⁵⁴^,⁵⁵^,⁷⁹^,⁴⁸^,⁵⁸^,⁶⁰^,⁶¹	8	³¹^,⁶²^,⁶³^,⁷¹^,⁶⁴^,⁶⁵^,⁶⁶^,⁶⁷^,⁶⁹^,83, 84, 85, 86, 87, 88^,⁸⁵
Not reported	4	⁵³^,⁵⁶^,⁵⁷^,⁵⁹^,⁷⁰^,⁸⁰	4	⁴⁹^,⁶⁸^,⁷⁸^,⁸⁴
C) Study outcomes
*Immunogenicity*
Seropositivity^a: Stratified by:	5	³⁰^,³²^,⁸¹^,⁸²^,51, 52, 53^,⁵⁴^,⁷⁹^,⁵⁶^,⁴⁸^,⁵⁷^,⁶⁰^,⁶¹^,⁸³	9	³¹^,⁶²^,⁶³^,⁶⁶^,⁴⁹^,⁵⁰^,⁶⁸^,⁶⁹^,⁷²^,⁷³^,⁷⁵^,⁷⁷^,⁷⁸^,⁸⁴^,⁸⁵
CD4 count/nadir	1	⁸²	1	⁶²
ART status	1	⁵³	0	−
Viral suppression	0	−	0	−
Geometric mean antibody titre (GMT): Stratified by:	6	³⁰^,³²^,⁴⁶^,⁸¹^,⁸²^,51, 52, 53^,⁵⁴^,⁴⁸^,⁵⁷^,77, 78, 79^,⁸³	6	³¹^,⁶²^,⁶³^,⁵⁰^,⁶⁹^,⁷³^,⁷⁶^,⁷⁷^,⁸⁴^,⁸⁵
CD4 count/nadir	1	⁸²	1	⁶²
ART status	1	⁵³	0	−
Viral suppression	1	⁵⁴	0	−
*Biological outcomes*
Genital warts	2	⁴⁶^,⁵⁵	0	−
Anogenital DNA infection	4	³²^,⁴⁶^,⁴⁷^,⁸²^,⁵⁵^,⁷⁹	3	³¹^,⁷¹^,⁶⁴^,⁷³
Cytology (anal/cervical)	0	−	2	⁷¹^,⁶⁴^,⁶⁵
Histology (CIN2+)	1	⁵⁵	0	−
*Safety*
AEs (possibly, probably or definitely related to vaccine)	3	³²^,⁴⁶^,⁵²^,⁵³^,⁷⁹^,⁵⁶^,⁵⁷^,⁶⁰^,⁶¹	2	⁶²^,⁶⁴^,⁶⁵^,⁶⁶^,⁶⁹
Any AEs	7	³⁰^,³²^,46, 47, 48, 49^,51, 52, 53^,⁵⁴^,58, 60, 59^,⁴⁸^,⁵⁷^,⁵⁸^,⁶⁰^,⁶¹^,⁸⁰^,⁸³	7	³¹^,⁶²^,⁷¹^,⁶⁴^,⁶⁵^,⁶⁶^,⁴⁹^,⁵⁰^,⁶⁹^,⁷³^,⁷⁴^,87, 88, 89^,⁸⁴^,⁸⁵
(S)AEs	7	30, 32, 46, 72, 52, 53, 55, 60, 75, 77, 78, 79, 59, 90, 48, 49, 91	7	³¹^,⁶²^,⁷¹^,⁶⁴^,⁶⁵^,⁶⁶^,⁴⁹^,⁵⁰^,⁶⁹^,83, 84, 85^,87, 88, 89^,⁸⁴^,⁸⁵

The proportion of the population that is seropositive for any of the HPV vaccine types at any point in time regardless of baseline HPV status; (S)AEs = (serious) Adverse Events, CIN = Cervical intraepithelial neoplasia; N_p: Number of publications; N_s: Number of independent trials; ^//Children if participants are < 18 years old and adults if ≥ 18 years old; ^♯ Range between 7 and 18 years old; ^❖ Historical control group based on participants recruited in a different study, time, location; ⁺All compare vaccine in HIV positive and negative participants.