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.