Table 5.

Solicited local and systemic reactions during the first week after the first dose of vaccine and the second dose of vaccine or placebo in pregnant women living with HIV

		First week after first vaccination			First week after second vaccination
		Single-dose and two-single-doses groups (n=517)	Double-dose group (n=255)	p value	Single-dose group (placebo; n=240)	Two-single-doses group (n=238)	p value
Non-dominant arm local injection-site reactions
Tenderness
	Any	24·6% (20·9–28·5)	28·3% (22·8–34·2)	0·27	15·0% (10·7–20·2)	18·5% (13·8–24·0)	0·31
	Severe	2·7% (1·5–4·5)	1·6% (0·4–4·0)	0·45	2·1% (0·7–4·8)	0·4% (<0·1–2·3)	0·22
Redness
	Any	7·0% (4·9–9·5)	7·8% (4·9–11·9)	0·66	2·1% (0·7–4·8)	3·4% (1·5–6·5)	0·42
	Severe	1·9% (0·9–3·5)	2·0% (0·6–4·5)	0·99	1·3% (0·3–3·6)	0·4% (<0·1–2·3)	0·62
Swelling
	Any	8·3% (6·1–11·0)	6·3% (3·6–10·0)	0·32	2·9% (1·2–5·9)	4·2% (2·0–7·6)	0·45
	Severe	1·7% (0·8–3·3)	2·0% (0·6–4·5)	0·78	1·7% (0·5–4·2)	0·4% (<0·1–2·3)	0·37
Hardness
	Any	19·9% (16·6–23·6)	22·0% (17·0–27·5)	0·51	11·7% (7·9–16·4)	15·6% (11·2–20·8)	0·22
	Severe	2·1% (1·1–3·8)	1·2% (0·2–3·4)	0·57	2·1% (0·7–4·8)	0·4% (<0·1–2·3)	0·22
Bruising
	Any	12·4% (10·0–15·5)	9·8% (6·4–14·1)	0·29	8·8% (5·5–13·1)	9·2% (5·9–13·7)	0·85
	Severe	0·8% (0·2–2·0)	0·8% (<0·1–2·8)	1·0	0·4% (<0·1–2·3)	0	1·0
Itching
	Any	19·0% (15·7–22·6)	22·8% (17·7–28·4)	0·22	12·5% (8·6–17·4)	13·0% (9·0–18·0)	0·86
	Severe	1·9% (0·9–3·5)	0·4% (<0·1–2·2)	0·11	0	0·8% (0·1–3·0)	0·50
At least one local reaction
	Any	38·1% (33·9–42·4)	47·8% (41·6–54·1)	0·010	23·8% (18·5–29·6)	28·2% (22·5–34·3)	0·27
	Severe	6·6% (4·6–9·1)	4·7% (2·5–8·1)	0·30	4·2% (2·0–7·5)	1·7% (0·5–4·2)	0·17
Dominant arm local injection-site reactions
Tenderness
	Any	19·5% (16·2–23·2)	22·0% (17·0–27·5)	0·43	··	··	··
	Severe	1·4% (0·1–2·5)	1·2% (0·2–3·4)	0·99	··	··	··
Redness
	Any	4·5% (2·8–6·6)	6·3% (3·6–10·0)	0·28	··	··	··
	Severe	0·6% (0·1–1·7)	2·4% (0·9–5·0)	0·066	··	··	··
Swelling
	Any	4·1% (2·5–6·1)	6·3% (3·6–10·0)	0·18	··	··	··
	Severe	0·8% (0·2–2·0)	2·0% (0·6–4·5)	0·17	··	··	··
Hardness
	Any	14·1% (11·2–17·4)	18·0% (13·5–23·3)	0·16	··	··	··
	Severe	0·8% (0·2–2·0)	1·2% (0·2–3·4)	0·69	··	··	··
Bruising
	Any	9·3% (6·9–12·1)	9·4% (6·1–13·7)	0·95	··	··	··
	Severe	0·4% (0·1–1·4)	0	1·0	··	··	··
Itching
	Any	12·8% (10·0–16·0)	18·0% (13·5–23·3)	0·050	··	··	··
	Severe	1·2% (0·4–2·5)	1·2% (0·2–3·4)	1·0	··	··	··
At least one local reaction
	Any	26·7% (22·9–30·7)	38·8% (32·8–45·1)	0·001	··	··	··
	Severe	3·7% (2·2–5·7)	5·1% (2·7–8·6)	0·35	··	··	··
Systemic reactions
Weakness or tiredness
	Any	35·8% (31·6–40·1)	34·9% (29·1–41·1)	0·81	27·5% (22·0–33·6)	24·0% (18·7–29·9)	0·38
	Severe	6·0% (4·1–8·4)	2·8% (1·1–5·6)	0·050	6·3% (3·5–10·1)	2·9% (1·2–6·0)	0·084
Headache
	Any	35·2% (31·1–39·5)	32·6% (26·8–38·7)	0·47	30·0% (24·3–36·2)	24·4% (19·1–30·3)	0·17
	Severe	6·0% (4·1–8·4)	2·0% (0·6–4·5)	0·011	4·2% (2·0–7·5)	2·5% (0·9–5·4)	0·32
Fever
	Any	4·3% (2·7–6·4)	1·6% (0·4–4·0)	0·057	3·8% (1·7–7·0)	3·8% (1·7–7·1)	0·99
	Severe	0·8% (0·2–2·0)	0	0·31	0·4% (<0·1–2·3)	0·8% (0·1–3·0)	0·62
Joint pain
	Any	19·5% (16·2–23·2)	20·0% (15·3–25·4)	0·88	16·3% (11·8–21·5)	11·8% (8·0–16·5)	0·16
	Severe	2·7% (1·5–4·5)	1·2% (0·2–3·4)	0·20	2·1% (0·7–4·8)	1·3% (0·3–3·6)	0·72
Muscle pain
	Any	17·8% (14·6–21·4)	21·2% (16·3–26·7)	0·26	18·3% (13·6–23·8)	11·3% (7·6–16·1)	0·032
	Severe	2·3% (1·2–4·0)	2·0% (0·6–4·5)	1·0	2·1% (0·7–4·8)	0·8% (0·1–3·0)	0·45
Rigors
	Any	5·8% (3·9–8·2)	5·5% (3·0–9·0)	0·86	3·8% (1·7–7·0)	3·8% (1·7–7·1)	1·0
Increased sweating
	Any	8·9% (6·6–11·7)	7·1% (4·2–10·9)	0·38	5·0% (2·6–8·6)	7·6% (4·5–11·7)	0·25
At least one systemic reaction
	Any	50·3% (45·9–54·7)	52·9% (46·6–59·2)	0·49	42·9% (36·6–49·4)	34·5% (28·4–40·9)	0·058
	Severe	10·4% (7·9–13·4)	5·5% (3·0–9·0)	0·022	8·3% (5·2–12·6)	5·5% (2·9–9·2)	0·22

Data are incidence with 95% CI in parentheses. Any reaction means all cases, irrespective of intensity.