Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) for HPV Vaccine for Males
Evidence of benefits, harms, values and preferences, and cost-effectiveness were reviewed in accordance with GRADE methods (Ahmed F, et al). The primary policy question was "Should HPV4 be recommended for routine use in 11-12 year old boys." The benefits considered included prevention of genital warts, anal intraepithelial neoplasia (AIN), and anal cancer. The harms considered included serious adverse events (SAE), venous thromboembolism (VTE), syncope, and anaphylaxis. Data on efficacy were from a randomized clinical trial of HPV4 in males; data on adverse effects were from randomized clinical trials of HPV4 in males and females, and post-licensure studies of HPV4 in females. Evidence type for each study included a review of study design, risk of bias, inconsistency, indirectness, imprecision, and other considerations.
Recommendation Category A: Recommendation that applies to all persons in an age or risk-based group. Recommendation Category B: Recommendation for individual clinical decision making. Evidence Type 1: Randomized controlled trials, or overwhelming evidence from observational studies. Evidence Type 2: Randomized controlled trials with important limitations, or exceptionally strong evidence from observational studies. Evidence Type 3: Observational studies. Evidence Type 4: Clinical experience and observations, observational studies, or randomized controlled trials with notable limitations. Source: Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ; for the ACIP Evidence Based Recommendations Work Group (EBRWG). Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine 29(49):9171-6, 2011.
Tables for GRADE: HPV Vaccine for Males
Reference: from Package insert. Vaccine efficacy, risk difference, and number needed to vaccinate calculated with GRADEpro software
Reference: Package insert Gardasil (quadrivalent human papillomavirus types 6, 11, 16 and 18 HPV)
|Incidence in vaccinated
|Incidence in controls
|Summary risk ratio
|SAE||4723 (2 RCTs)||0.4%||0.5%||0.88
|Syncope||4723 (2 RCTs)||0.04%||0.1%||0.50
|VTE||4723 (2 RCTs)||0||0||NE|
|Anaphylaxis||4722 (2 RCTs)||0||0||NE|
|SAE||18,893 (4 RCTs)||1.1%||1.1%||0.97
|Syncope||18,893 (4 RCTs)||0.2%||0.2%||0.84
|VTE||18,893 (4 RCTs)||0.03%||0.02%||1.33
|Anaphylaxis||18,893 (4 RCTs)||0||0.01||0.33
NE= non estimable
aFrom Merck protocols 018 (follow-up 2.5 years), 020 (follow-up 3 years)
Summary risk ratio calculated using RevMan software, fixed effects
Reference: from Gee J, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine. 2011
Reference: ACIP C. Velicer
- C Velicer. ACIP Presentation. Post-licensure Safety Study of Quadrivalent Human Papillomavirus Vaccine among 189,629 Females [336 KB, 20 pages] Presented at October 2011 ACIP Meeting.
- Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ, for the ACIP Evidence Based Recommendations Work Group (EBRWG). Methods for developing evidence-based recommendations by the ACIP of the CDC. Vaccine 2011;29(49):9171-76.
- Bohlke K, Davis RL, DeStefano F, Marcy SM, Braun MM, Thompson RS; Vaccine Safety Datalink Team. Epidemiology of anaphylaxis among children and adolescents enrolled in a health maintenance organization. J Allergy Clin Immunol 2004;113:536-42.
- Chesson HW, Ekwueme DU, Saraiya M, Dunne EF, Markowitz LE. The cost-effectiveness of male HPV vaccination in the United States. Vaccine 2011;29:8443-50.
- Food and Drug Administration, Product approval information – licensing action, package insert: Gardasil (quadrivalent human papillomavirus types 6, 11, 16 and 18 HPV), Merck & Co. Whitehouse Station, NJ: Food and Drug Administration; 2009.
- Gee J, Naleway A, Shui I,et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine 2011;29:8279-84.
- Giuliano AR, Palefsky JM, Goldstone S, et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. N Engl J Med 2011;364:401-11.
- Palefsky JM, Giuliano AR, Goldstone S, et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med 2011;365:1576-85.
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