Table 1 In the Hybrid Group (baseline SARS-CoV-2 positive and received 1 mRNA-1273 dose), 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 (GM) (95% CI)

N

Proportion with Response over Baseline (95% CI)c

Geometric Mean (GM) (95% CI)

Response Frequency Difference (Non-Cases – Cases)

Ratio of GM (Non-Cases/Cases)

M0 IgG N Index (AU/ml)

152

N/A

17622 (13546, 22925)

135

N/A

55948 (41404, 75602)

N/A

3.17 (2.14, 4.72)

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

152

N/A

7900 (6103, 10227)

135

N/A

18477 (14457, 23614)

N/A

2.34 (1.64, 3.34)

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

152

N/A

109 (77.8, 152.7)

135

N/A

367.8 (267, 507)

N/A

3.37 (2.12, 5.38)

Peak IgG N Index (AU/ml)

152

0.7% (0.1%, 3.7%)

15110 (11958, 19093)

135

0.0% (0.0%, 2.8%)

33963 (25959, 44434)

−0.7% (−2.6%, 1.3%)

2.25 (1.58, 3.2)

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

152

92.7% (87.4%, 95.9%)

178506 (152321, 209192)

135

77.8% (70.0%, 84.0%)

213245 (181560, 250459)

−14.9% (−23.8%, −6.2%)

1.19 (0.95, 1.5)

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

152

96.7% (92.5%, 98.6%)

3022 (2212, 4130)

135

96.3% (91.6%, 98.4%)

4700 (3306, 6682)

−0.4% (−5.1%, 4.3%)

1.55 (0.98, 2.48)

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

19

100% (83.2%, 100.0%)

161629 (109200, 239232)

135

77.8% (70.0%, 84.0%)

213245 (181560, 250459)

−22.2% (15.2%, 29.2%)

1.32 (0.84, 2.07)

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

19

100% (83.2%, 100.0%)

1924 (899, 4116)

135

96.3% (91.6%, 98.4%)

4700 (3306, 6682)

−3.7% (0.52%, 6.89%)

2.44 (0.92, 6.48)

  1. aCases acquired a COVID-19 endpoint 7 days post Peak through 230 days post Peak.
  2. 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).
  3. 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).
  4. dFor these rows, cases restrict to those who acquired a COVID-19 endpoint 7 days post Peak through 92 days post Peak.
  5. Peak, 4 weeks post last vaccine dose (M1 for Hybrid Group); N, Nucleocapsid protein; nAb-ID50, 50% inhibitory serum dilution neutralizing antibody titer.
  6. Analysis based on eligible COVID-19 casesa and non-casesb from the Per-protocol Serum Immunogenicity Analysis Set.
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