Trial Outcomes & Findings for Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study (NCT NCT01824537)
NCT ID: NCT01824537
Last Updated: 2025-03-19
Results Overview
Participants (n=308) from new (≤6 months) heterosexual couples aged 18+ in Montreal, Canada, were randomized into 4 groups: Group 1: 40 males and 40 females; Group 2: 31 males and 31 females; Group 3: 39 males and 39 females; Group 4: 44 males and 44 females. Genital samples, collected at 0, 2, 4, 6, 9, and 12 months, were genotyped for 36 HPV types. For females and males separately within each of the 4 groups, we calculated, via time-to-event analyses, the incidence rates (and their jackknife 95% confidence intervals, CI) as the number of incident infections/1000 infection-months at risk. We used type-specific HPV infections as the unit of analysis; that is, each participant could contribute time at risk for up to the 9 vaccine-targeted (i.e., HPVs 6, 11, 16, 18, 31, 33, 45, 52, and 58) type-specific HPV-level infections. Participants contributed time at risk for incidence of type-specific HPV-level infections if they had not previously tested positive for that HPV type.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
372 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2025-03-19
Participant Flow
Participant milestones
| Measure |
HPV Vaccine, Gardasil 9
HPV vaccine intervention: The intervention vaccine will be Gardasil 9, a 9-valent vaccine by Merck. This vaccine was chosen because it allows for the observation of 9 HPV outcomes (HPV 6, 11, 16 and 18) (the other available vaccine, Cervarix, protects against HPVs 16 and 18, only).
HPV vaccine, Gardasil 9: Once recruited, both individuals in a couple will be randomized independently to Gardasil 9 or placebo (Avaxim).
|
Hepatitis A Vaccine
The placebo comparator will be Avaxim, by Sanofi Pasteur. This control vaccine was chosen because hepatitis A immunization provides a similar health prevention incentive as HPV vaccination to study participants while preserving the scientific cogency of a "placebo" comparator. Gardasil 9 requires administration of 3 doses, while Avaxim only requires 2 doses. For this reason, a placebo injection (saline solution) will be added in between the Avaxim vaccination regimen. Consequently, both treatment and control vaccines will have similar regimens, i.e., study entry, 2 months, and 6 months.
Hepatitis A vaccine: Provided by Sanofi Pasteur.
|
|---|---|---|
|
Overall Study
STARTED
|
190
|
182
|
|
Overall Study
COMPLETED
|
112
|
95
|
|
Overall Study
NOT COMPLETED
|
78
|
87
|
Reasons for withdrawal
| Measure |
HPV Vaccine, Gardasil 9
HPV vaccine intervention: The intervention vaccine will be Gardasil 9, a 9-valent vaccine by Merck. This vaccine was chosen because it allows for the observation of 9 HPV outcomes (HPV 6, 11, 16 and 18) (the other available vaccine, Cervarix, protects against HPVs 16 and 18, only).
HPV vaccine, Gardasil 9: Once recruited, both individuals in a couple will be randomized independently to Gardasil 9 or placebo (Avaxim).
|
Hepatitis A Vaccine
The placebo comparator will be Avaxim, by Sanofi Pasteur. This control vaccine was chosen because hepatitis A immunization provides a similar health prevention incentive as HPV vaccination to study participants while preserving the scientific cogency of a "placebo" comparator. Gardasil 9 requires administration of 3 doses, while Avaxim only requires 2 doses. For this reason, a placebo injection (saline solution) will be added in between the Avaxim vaccination regimen. Consequently, both treatment and control vaccines will have similar regimens, i.e., study entry, 2 months, and 6 months.
Hepatitis A vaccine: Provided by Sanofi Pasteur.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
78
|
87
|
Baseline Characteristics
Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study
Baseline characteristics by cohort
| Measure |
Female: Hepatitis A Vaccine
n=71 Participants
The placebo comparator will be Avaxim, by Sanofi Pasteur. This control vaccine was chosen because hepatitis A immunization provides a similar health prevention incentive as HPV vaccination to study participants while preserving the scientific cogency of a "placebo" comparator. Gardasil 9 requires administration of 3 doses, while Avaxim only requires 2 doses. For this reason, a placebo injection (saline solution) will be added in between the Avaxim vaccination regimen. Consequently, both treatment and control vaccines will have similar regimens, i.e., study entry, 2 months, and 6 months.
Hepatitis A vaccine: Provided by Sanofi Pasteur.
|
Female: HPV Vaccine, Gardasil 9
n=83 Participants
HPV vaccine intervention: The intervention vaccine will be Gardasil 9, a 9-valent vaccine by Merck. This vaccine was chosen because it allows for the observation of 9 HPV outcomes (HPV 6, 11, 16 and 18) (the other available vaccine, Cervarix, protects against HPVs 16 and 18, only).
HPV vaccine, Gardasil 9: Once recruited, both individuals in a couple will be randomized independently to Gardasil 9 or placebo (Avaxim).
|
Male: Hepatitis A Vaccine
n=79 Participants
The placebo comparator will be Avaxim, by Sanofi Pasteur. This control vaccine was chosen because hepatitis A immunization provides a similar health prevention incentive as HPV vaccination to study participants while preserving the scientific cogency of a "placebo" comparator. Gardasil 9 requires administration of 3 doses, while Avaxim only requires 2 doses. For this reason, a placebo injection (saline solution) will be added in between the Avaxim vaccination regimen. Consequently, both treatment and control vaccines will have similar regimens, i.e., study entry, 2 months, and 6 months.
Hepatitis A vaccine: Provided by Sanofi Pasteur.
|
Male: HPV Vaccine, Gardasil 9
n=75 Participants
HPV vaccine intervention: The intervention vaccine will be Gardasil 9, a 9-valent vaccine by Merck. This vaccine was chosen because it allows for the observation of 9 HPV outcomes (HPV 6, 11, 16 and 18) (the other available vaccine, Cervarix, protects against HPVs 16 and 18, only).
HPV vaccine, Gardasil 9: Once recruited, both individuals in a couple will be randomized independently to Gardasil 9 or placebo (Avaxim).
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
24.2 years
STANDARD_DEVIATION 4.7 • n=99 Participants
|
25.4 years
STANDARD_DEVIATION 6.2 • n=107 Participants
|
25.7 years
STANDARD_DEVIATION 5.7 • n=206 Participants
|
26.7 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
25.5 years
STANDARD_DEVIATION 6.0 • n=31 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
154 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
154 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Birth Country · Canada
|
39 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
152 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Birth Country · United States
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Birth Country · Other: Brazil, China, Mexico, MENA, Sub-Saharan Africa, Latin America, Europe, Asia, Oceania
|
27 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
132 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Birth Country · Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Education
High school
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
|
Education
College or vocational training
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
55 Participants
n=31 Participants
|
|
Education
University
|
51 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
198 Participants
n=31 Participants
|
|
Education
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Smoking Status
Never
|
52 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
216 Participants
n=31 Participants
|
|
Smoking Status
Former
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
66 Participants
n=31 Participants
|
|
Smoking Status
Current
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Smoking Status
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Concurrent sex partners
No
|
58 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
60 Participants
n=7 Participants
|
259 Participants
n=31 Participants
|
|
Concurrent sex partners
Yes
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Concurrent sex partners
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Number of lifetime vaginal sex partners
|
5 partners
n=99 Participants
|
6 partners
n=107 Participants
|
8 partners
n=206 Participants
|
7 partners
n=7 Participants
|
6 partners
n=31 Participants
|
|
Age at coitarche
|
17 years
n=99 Participants
|
17.5 years
n=107 Participants
|
18 years
n=206 Participants
|
18 years
n=7 Participants
|
18 years
n=31 Participants
|
|
Years since onset of sexual activity
|
4.8 years
n=99 Participants
|
5.4 years
n=107 Participants
|
6 years
n=206 Participants
|
7.6 years
n=7 Participants
|
5.8 years
n=31 Participants
|
|
Grouped HPV positivity
Vaccine-targeted (any 9vHPV)
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
55 Participants
n=31 Participants
|
|
Grouped HPV positivity
Any HPV
|
34 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
134 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The analytical population consists of 82.8% of participants (154 couples=308 participants) who had at least one follow-up visit, and valid baseline genital samples from both partners or values imputed based on subsequent visits. Each participant contributed 9 observations, 1 for each of the 9 HPV types. In group 1, 720 units analyzed=80 participantsx9 HPV types. For each of the 4 groups, we report one incidence rate for males, and one for females, for a total of 8 incidence rate values.
Participants (n=308) from new (≤6 months) heterosexual couples aged 18+ in Montreal, Canada, were randomized into 4 groups: Group 1: 40 males and 40 females; Group 2: 31 males and 31 females; Group 3: 39 males and 39 females; Group 4: 44 males and 44 females. Genital samples, collected at 0, 2, 4, 6, 9, and 12 months, were genotyped for 36 HPV types. For females and males separately within each of the 4 groups, we calculated, via time-to-event analyses, the incidence rates (and their jackknife 95% confidence intervals, CI) as the number of incident infections/1000 infection-months at risk. We used type-specific HPV infections as the unit of analysis; that is, each participant could contribute time at risk for up to the 9 vaccine-targeted (i.e., HPVs 6, 11, 16, 18, 31, 33, 45, 52, and 58) type-specific HPV-level infections. Participants contributed time at risk for incidence of type-specific HPV-level infections if they had not previously tested positive for that HPV type.
Outcome measures
| Measure |
Group 1 - Male and Female: Hepatitis A Vaccine
n=720 type-specific HPV (participant-HPV unit)
Both participants of the couple were administered the active control Avaxim Hepatitis A vaccine, by Sanofi Pasteur. Gardasil 9 requires administration of 3 doses, while Avaxim only requires 2 doses. For this reason, a placebo injection (saline solution) was added in between the Avaxim vaccination regimen. Consequently, this regimen was given at study entry, 2 months, and 6 months.
|
Group 2 - Male: Gardasil 9; Female: Hepatitis A Vaccine
n=558 type-specific HPV (participant-HPV unit)
The male was administered the Gardasil 9 vaccine, by Merck, while the female was administered the Avaxim Hepatitis A vaccine, by Sanofi Pasteur, with a placebo injection (saline solution) added in between the Avaxim vaccination regimen. Consequently, both treatment and active control vaccines had similar regimens, i.e., study entry, 2 months, and 6 months.
|
Group 3 - Male: Hepatitis A Vaccine; Female: Gardasil 9
n=702 type-specific HPV (participant-HPV unit)
The male was administered the Avaxim Hepatitis A vaccine, by Sanofi Pasteur, with a placebo injection (saline solution) added in between the Avaxim vaccination regimen, while the female was administered the Gardasil 9 vaccine, by Merck. Consequently, both treatment and active control vaccines had similar regimens, i.e., study entry, 2 months, and 6 months.
|
Group 4 - Male and Female: Gardasil 9
n=792 type-specific HPV (participant-HPV unit)
Both participants of the couple were administered the Gardasil 9 vaccine, by Merck. Gardasil 9 requires administration of 3 doses, which was given at study entry, 2 months, and 6 months.
|
|---|---|---|---|---|
|
HPV Incidence Rates, Expressed as Incident Infections/1000 Infection-months at Risk. These Were Calculated Separately for Females and Males Across the Four Vaccine Assignment Groups.
Female-HPV incidence rate
|
1.40 incident infections/1000 infection-month
Interval 0.51 to 5.34
|
1.58 incident infections/1000 infection-month
Interval 0.55 to 6.17
|
1.05 incident infections/1000 infection-month
Interval 0.42 to 3.45
|
1.58 incident infections/1000 infection-month
Interval 0.71 to 4.25
|
|
HPV Incidence Rates, Expressed as Incident Infections/1000 Infection-months at Risk. These Were Calculated Separately for Females and Males Across the Four Vaccine Assignment Groups.
Male-HPV incidence rate
|
2.42 incident infections/1000 infection-month
Interval 0.97 to 7.63
|
0.99 incident infections/1000 infection-month
Interval 0.17 to 3.07
|
3.35 incident infections/1000 infection-month
Interval 1.95 to 6.3
|
1.67 incident infections/1000 infection-month
Interval 0.75 to 3.51
|
Adverse Events
HPV Vaccine, Gardasil 9
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hepatitis A Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place