NCT02968420: Merck08

Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine

Completed Phase 4 Results posted Last updated 25 June 2021

What this trial tests

Phase 4 trial testing Human Papillomavirus 9-valent Vaccine, Recombinant in Human Papillomavirus in 18 participants. Completed in 15 May 2019.

Timeline

11 September 2017

Primary endpoint
15 May 2019

15 May 2019

Quick facts

Lead sponsor	University of British Columbia
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	11 September 2017
Primary completion	15 May 2019
Estimated completion	15 May 2019
Sites	1 location across Canada

Drugs / interventions tested

• Human Papillomavirus 9-valent Vaccine, Recombinant — full drug profile →

Conditions studied

• Human Papillomavirus — all drugs for Human Papillomavirus →

Sponsor

University of British Columbia

Who can join

Adults 17 to 35, female only, with Human Papillomavirus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

B Memory Cell Response (% of Memory B Cells That Are Antigen-specific) Primary · At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine

To compare the B memory cell populations between girls that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose after 120 months

HPV16

Group	Value	95% CI
Group 1	0.61	± 0.49
Group 2	0.94	± 0.94
Group 3	0.36	± 0.23

HPV18

Group	Value	95% CI
Group 1	0.08	± 0.18
Group 2	0.11	± 0.13
Group 3	0.03	± 0.05

Plasmablast Response (% of All B Cells That Are Plasmablasts) Primary · At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine

To compare the plasmablast populations between girls that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose after 120 months

Group	Value	95% CI
Group 1	2.37	± 2.51
Group 2	3.14	± 3.53
Group 3	5.37	± 6.46

Serum Antibody Response (cLIA) - Geometric Mean Titer Secondary · At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine

To compare the serum antibody responses (cLIA) to HPV 6, 11, 16 \& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose

HPV6

Group	Value	95% CI
Group 1	338	111 – 1027
Group 2	1864	1411 – 2461
Group 3	699	129 – 3780

HPV11

Group	Value	95% CI
Group 1	1277	592 – 2753
Group 2	5071	2361 – 10892
Group 3	3807	1096 – 13224

HPV16

Group	Value	95% CI
Group 1	4922	1765 – 13731
Group 2	15237	6966 – 33328
Group 3	10122	3475 – 29481

HPV18

Group	Value	95% CI
Group 1	855	461 – 1585
Group 2	2140	897 – 5105
Group 3	807	305 – 2134

Serum Antibody Response (cLIA) - Geometric Mean Titer Secondary · At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine

To compare the serum antibody responses (cLIA) to HPV 6, 11, 16 \& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose

HPV6

Group	Value	95% CI
Group 1	1313	376 – 4586
Group 2	2722	1472 – 5033
Group 3	815	135 – 4924

HPV11

Group	Value	95% CI
Group 1	3430	1418 – 8299
Group 2	6042	3255 – 11214
Group 3	5778	2919 – 11439

HPV16

Group	Value	95% CI
Group 1	21135	11337 – 39399
Group 2	21768	11797 – 40170
Group 3	18930	11126 – 32208

HPV18

Group	Value	95% CI
Group 1	3326	1197 – 9245
Group 2	2615	1033 – 6620
Group 3	1312	676 – 2548

Serum Antibody Response (Total IgG) - Geometric Mean Titer Secondary · At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine

To compare the serum antibody responses (total IgG) to HPV 6, 11, 16 \& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose

HPV6

Group	Value	95% CI
Group 1	1263	437 – 3650
Group 2	6079	3682 – 10036
Group 3	3712	1036 – 13302

HPV11

Group	Value	95% CI
Group 1	1009	308 – 3306
Group 2	5184	2644 – 10164
Group 3	3371	947 – 11997

HPV16

Group	Value	95% CI
Group 1	4715	1358 – 16368
Group 2	10962	3489 – 34438
Group 3	7607	1379 – 41972

HPV18

Group	Value	95% CI
Group 1	1418	450 – 4473
Group 2	3694	1522 – 8964
Group 3	946	296 – 3026

Serum Antibody Response (Total IgG) - Geometric Mean Titer Secondary · At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine

To compare the serum antibody responses (total IgG) to HPV 6, 11, 16 \& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose

HPV6

Group	Value	95% CI
Group 1	4579	1930 – 10865
Group 2	7308	4781 – 11172
Group 3	7371	3757 – 14460

HPV11

Group	Value	95% CI
Group 1	3234	1016 – 10297
Group 2	6637	3810 – 11559
Group 3	6271	3309 – 11884

HPV16

Group	Value	95% CI
Group 1	25808	10472 – 63603
Group 2	32051	18808 – 54618
Group 3	12364	2957 – 51689

HPV18

Group	Value	95% CI
Group 1	6363	2371 – 17082
Group 2	4985	1737 – 14304
Group 3	1813	805 – 4082

Sponsor's own description

The overall aim of this study is to further understand the memory response to HPV vaccination in subjects who have received 2 versus 3 doses of quadrivalent HPV vaccine. Although memory responses can be detected shortly after immunization, the best approach to measure the long-lasting anamnestic response is to challenge with a booster dose years (\> 5) after the original exposure.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.