Table 1 Summary of findings.

From: Efficacy and safety of human papillomavirus vaccination in HIV-infected patients: a systematic review and meta-analysis

Outcomesa

Anticipated absolute effectsb

Relative effect (95% CI)

No. of participants (studies)

Certainty of evidence (GRADE)

Comments

Baseline risk in placebo group

Risk in vaccine group

Primary outcomes

Immunogenicity—HPV 16

Study population

MD = 4333.3 GMT EL.U/ml (2701.4–5965.1)

199 (2)

High

 ⊕  ⊕  ⊕  ⊕ 

 

16.6 GMT EL.U/ml

4350.0 GMT EL.U/ml

Immunogenicity—HPV 18

Study population

MD = 1404.8 GMT EL.U/ml (414.8–2394.7)

200 (2)

High

 ⊕  ⊕  ⊕  ⊕ 

 

9.8 GMT EL.U/ml

1414.6 GMT EL.U/ml

Not serious adverse events

Study population

RR = 1.0 (0.9–1.2)

375 (3)

High

 ⊕  ⊕  ⊕  ⊕ 

 

932 events per 1000 subjects

947 events per 1000 subjects

Serious adverse events

Study population

RR = 0.6 (0.2–1.6)

949 (4)

High

 ⊕  ⊕  ⊕  ⊕ 

 

50 events per 1000 subjects

32 events per 1000 subjects

Secondary outcomes

CD4 + T-cell count—after vaccination series

Study population

MD = 14.8 cells/µl (− 35.1 to 64.6)

364 (3)

High

 ⊕  ⊕  ⊕  ⊕ 

 

702 cells/µl

717 cells/µl

HIV viral load—after vaccination series

Study population

MD = 0.0 log10 RNA copies/ml (− 0.3 to 0.3)

235 (2)

High

 ⊕  ⊕  ⊕  ⊕ 

 

3.7 log10 RNA copies/ml

3.7 log10 RNA copies/ml

Completion rate

Study population

RR = 1.0 (1.0–1.0)

949 (4)

High

 ⊕  ⊕  ⊕  ⊕ 

 

973 events per 1000 subjects

974 events per 1000 subjects

  1. Population: HIV-infected subjects.
  2. Setting: any; studies conducted in: South Africa, Spain, USA, Brazil.
  3. Intervention: bivalent or quadrivalent HPV Vaccine.
  4. Comparison: placebo.
  5. aThe present summary of findings only considers primary and secondary outcome that were present in more than one study and that were eligible for data synthesis.
  6. bFor quantitative outcomes, the absolute baseline risk was the median value calculated over the mean values reported for the vaccine group in the included studies, whereas for dichotomous outcomes it was the median value calculated over the risks reported for the vaccine group in the included studies. The absolute risks in vaccine groups were calculated using the anticipated absolute effect in the placebo group and the relative effect measure. 95% CI 95% confidence interval, RR risk ratio, MD mean difference. GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect; Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different; Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect; Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. Criteria for grading of evidence: study design and risk of bias of included studies, indirectness of evidence, inconsistency and imprecision of relative effect estimates, publication bias.
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