Table 4 In the Vaccine Group (SARS-CoV-2 baseline negative and received 2 mRNA-1273 doses), vaccine-response frequencies at Peak by COVID-19 outcome status, geometric means (GMs) by COVID-19 outcome status, and their comparisons between non-cases and cases

From: Neutralizing and binding antibodies are a correlate of risk of COVID-19 in the CoVPN 3008 study in people with HIV

 

COVID-19 Casesa

Non-Casesb

Comparison

Marker

N

Proportion with Response over Baseline (95% CI)c

Geometric Mean

N

Proportion with Response over Baseline (95% CI)c

Geometric Mean

Response Frequency Difference (Non-Cases – Cases)

Ratio of GM (Non-Cases/Cases)

M0 IgG N Index (AU/ml)

54

N/A

4837 (3661, 6391)

61

N/A

4831 (3481, 6703)

N/A

1.0 (0.65, 1.54)

M0 IgG Spike BA.4/5 (AU/ml)

54

N/A

586 (376, 913)

61

N/A

538 (359, 806)

N/A

0.92 (0.51, 1.66)

M0 nAb ID50 BA.4/5 (AU/ml)

54

N/A

13.8 (8.1, 23.3)

61

N/A

10.5 (7.1, 15.7)

N/A

0.76 (0.4, 1.45)

Peak IgG N Index (AU/ml)

54

3.9% (1.1%, 13.2%)

4342 (3382, 5575)

61

1.8% (0.3%, 9.3%)

4342 (3172, 5945)

−2.1% (−9.8%, 5.6%)

1 (0.67, 1.5)

Peak IgG Spike BA.4/5 (AU/ml)

54

100.0% (93.4%, 100.0%)

102310 (78986, 132523)

61

100.0% (94.0%, 100.0%)

120017 (91598, 157253)

0% (0%, 0%)

1.17 (0.81, 1.7)

Peak nAb ID50 BA.4/5 (AU/ml)

54

92.6% (82.5%, 97.1%)

788 (396, 1566)

61

95.1% (86.5%, 98.3%)

757 (439, 1306)

2.5% (−8.1%, 13.1%)

0.96 (0.41, 2.27)

Peak IgG Spike BA.4/5 (AU/ml) vs. D7-92 casesd

14

100% (78.5%, 100.0%)

84534 (48463, 147451)

61

100.0% (94.0%, 100.0%)

120017 (91598, 157253)

0% (−1.55%, 4.83%)

1.42 (0.77, 2.62)

Peak nAb ID50 BA.4/5 (AU/ml) vs. D7-92 casesd

14

85.7% (60.1%, 96.0%)

230 (51, 1045)

61

95.1% (86.5%, 98.3%)

757 (439, 1306)

9.4% (−28.48%, 9.75%)

3.29 (0.89, 12.26)

  1. Analysis based on eligible COVID-19 casesa and non-casesb from the Per-protocol Serum Immunogenicity Analysis Set.
  2. Peak, 4 weeks post last vaccine dose (M2 for Vaccine Group); N Nucleocapsid protein, nAb-ID50, 50% inhibitory serum dilution neutralizing antibody titer.
  3. aCases acquired a COVID-19 endpoint 7 days post Peak through 230 days post Peak.
  4. bNon-cases did not have a positive RT-PCR result at the Peak visit and did not acquire a COVID-19 endpoint after M0 up to the date by which the last enrolled participant reached 230 days post Peak (March 31, 2023).
  5. cAt Peak, a vaccine response (sero-response) for IgG N Index or IgG Spike BA.5 is defined as participants with value above the antigen-specific positivity cut-off (if the M0 readout is below the positivity cut-off) or is at least 4-fold above the M0 value (if the M0 readout is above the positivity cut-off) (positivity cut-off = 3970 AU/ml for N Index and 48.6 AU/ml for Spike BA.5); positive sero-response for nAb ID50 BA.4/5 is defined as participants with value above the LOD (if the M0 readout is below the LOD) or is at least 4-fold above the M0 value (if the M0 readout is above the LOD).
  6. dFor these rows cases restrict to those who acquired a COVID-19 endpoint 7 days post Peak through 92 days post Peak.
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