30 years of rabies vaccination with Rabipur: a summary of clinical data and global experience

Figures & data

Table 6. Summary of Rabipur efficacy following PEP administration.

Regimen	Total subjects	Subjects bitten by proven rabid animals	Subjects who received RIG/HRIG	Follow-up period (months)	Survival rate^† (%)	Ref.
IM 6-dose Essen^‡	45^§	45	45 (HRIG)	>12	100	[115]
IM 6-dose Essen^‡	69	69	32 (HRIG); 7 with history of nerve tissue vaccine	12	100	[96,97]
IM 6-dose Essen^‡	21	21	4 (HRIG)	15	100	[116]
IM 6-dose Essen^‡	56	56	41 (HRIG)	19–34	100	[117]
IM 6-dose Essen^‡	14	14	14 (HRIG)	6	100	[118]
Exploratory 4-site ID (4-4-4-1-1)	29	4	–	16	100	[103]
IM 3- or 6-dose	82	82	37 (RIG)	12	100	[55]
IM 5- or 6-dose	271	27	–	–	100	[65]
IM 2- to 6-dose	1252	145	No RIG	>12	100	[64]
Oxford 8-site ID	32	32	22 (HRIG/ERIG)	36	100	[106]
Thai Red Cross 2-site ID^¶	148	148	<3% (ERIG)	≥12	100	[119]
Thai Red Cross 2-site ID^¶	113	113	113 (HRIG/ERIG)	≥12	100	[53]
Thai Red Cross 2-site ID	58	3	58 (ERIG)	12	100^#	[111]

^†Efficacy outcome endpoints in survival rate after bite by laboratory-proven rabid animal.

^‡Vaccination on Days 0, 3, 7, 14, 30 and 90. Current Essen regimen recommended by the WHO is a 5-dose IM regimen.

^§Two additional patients were followed up to 7 months due to timing of publication.

^¶Vaccination on Days 0, 3 and 7 (2-sites) and on Days 30 and 90 (1-site). Current WHO recommendation is an ID 2-site (updated Thai Red Cross) regimen with doses on Days 0, 3, 7 and 28 (2-sites).

^#Only patients with laboratory-confirmed rabies were followed for 1 year.

ERIG: Equine rabies immunoglobulin; HRIG: Human rabies immunoglobulin; ID: Intradermal; IM: Intramuscular; PEP: Post-exposure prophylaxis; RIG: Rabies immunoglobulin.

Table 1. Summary of Rabipur intramuscular PEP and PrEP immunogenicity and safety studies in adults.

Regimen	Country	Vaccination days (dose series)	Immunogenicity Adequate immune response (RVNA ≥0.5 IU/ml)	Safety	Ref.
PEP 6-dose Essen	Austria	0, 3, 7, 14, 30, 90^† (1-1-1-1-1-1)	100% by Day 14 and up to Day 100; (n = 15)	Well tolerated, mild pain at injection site; n = 4/14 (29%)	[92]
3-dose (3 different sites) PrEP 3-dose	Germany	0 (3) 0, 7, 21 booster at 420 (1-1-1) + 1	RVNA on Day 14: 0.37–5.46 IU/ml; (n = 23) 100% by Day 30; anamnestic immune responses in all subjects by Day 14 after booster dose; (n = 20)	Well tolerated, pain at injection site, small local erythemas – not specific	[93,94]
PEP 6-dose Essen	Germany	0, 3, 7, 14, 30, 90^† (1-1-1-1-1-1)	100% by Day 14 to over 1 year; (n = 31)	Well tolerated, mild pain at injection site; n = 4/31 (13%)	[92,94,95]
PEP 6-dose Essen	Croatia^‡	0, 3, 7, 14, 30, 90^† (1-1-1-1-1-1)	100% by Day 30 to over 1 year; (n = 64)	Well tolerated, mild pain at injection site; n = 2/64 (3%)	[92,94]
PrEP 3-dose	Croatia	0, 7, 21 (1-1-1)	100% by Day 35 to over 1 year; (n = 23)	Well tolerated, mild pain at injection site; n = 2/23 (9%)	[92,95]
PEP 6-dose Essen + HRIG on Day 0	Croatia	0, 3, 7, 14, 30, 90^† (1-1-1-1-1-1)	100% by Day 30 and up to Day 100; (n = 26)		[92,95]
PrEP 3-dose	Thailand	0, 7, 21 (1-1-1)	100% by Day 21; (n = 22)	In 69 IM injections the volunteers complained of local pain (62x), local erythema (9x) and local itching (4x) Mild general reaction temperatures between 37.5 and 38°C (11x), headaches (6x) and malaise (7x)	[93,94,96]
PrEP 3-dose	Croatia	0, 7, 21 (1-1-1)	100% by Day 30; (n = 15)	Well tolerated, mild pain at injection site	[94]
PEP 6-dose + HRIG on Day 0	Croatia	0, 3, 7, 14, 30, 90^† (1-1-1-1-1-1)	100% by Day 14; (n = 20)	Well tolerated, mild pain at injection site	[94]
PEP 6-dose Essen +/- HRIG	Thailand	0, 3, 7, 14, 30, 90^† (1-1-1-1-1-1)	100% by Day 14; (n = 58)	Safety (n = 68). Pain at injection site (7x), headache (2x)	[94,96,97]
PEP 4-dose Zagreb PEP 4-dose Zagreb + HRIG PrEP 4-dose Zagreb	Croatia	0, 7, 21 (2-1-1) (2-1-1)	100% by Day 14; (n = 34) 100% by Day 14 and 96% by Day 90; (n = 23)	N/A	[32,50]
PEP 6-dose Essen PEP 5-dose Essen PrEP 3-dose	Germany	0, 3, 7, 14, 30, 90^† (1-1-1-1-1-1) 0, 3, 7, 14, 30 (1-1-1-1-1) 0, 7, 21 (1-1-1)	100% by Day 14 and up to Day 180 in all regimens; (n = 88)	Safety (n = 88 subjects) General reactions: systemic (31.2%); local reactions, mostly mild (56.5%). Moderate or severe reactions: systemic (15.1%); local (16.4%)	[48]
PrEP 3-dose	UK	0, 7, 21 or 0, 28, 56 (1-1-1)	100% by Day 21; (n = 177)	Well tolerated, mild pain at injection site Malaise, generalized aching and headache (3–5%) Local pain: PCECV (22.5%), HDCSV (21%) Local erythema: PCECV (2%), HDCSV (0%) Swelling: PCECV (5%), HDCSV (3%) Pruritis: PCECV (2%), HDCSV (1%)	[98]
PEP Exploratory 6-dose Essen +/- HRIG or ERIG	Thailand	0, 3, 7, 14, 28, 91^† (1-1-1-1-1-1) (3-0-0-1-1-1)	100% by Day 28; (n = 76)	Well tolerated, mild and moderate pain at injection site: PCEC (n = 37/76, 49%)	[99]
PEP 3-dose (Category I exposure) PEP 6-dose Essen (Category II/III exposure) + ERIG for Category III exposures	India	0, 3, 7 (1-1-1) 0, 3, 7, 14, 30, 90^† (1-1-1-1-1-1)	100% by Day 14 (PEP 3-dose) and Day 37 (PEP 6-dose); (n = 60)	No systemic reactions. Local reactions (erythema, swelling, pain) in some cases, lymphadenopathy in 8%	[100]
PrEP 3-dose + booster	USA	0, 7, 28 booster at 756 (1-1-1)+1	100% by Day 28 up to Day 756; (n = 38) 100% on Day 7 after booster	Well tolerated, mild and moderate pain at injection site: HDCV (45%), PCEC (34%)	[33]
PEP 5-dose Essen	India	0, 3, 7, 14, 30 (1-1-1-1-1)	100% by Day 14 and Day 30; (n = 10)	N/A	[101]
PEP or PrEP Rabipur vaccination 2–14 years previously	Germany		100% RVNA of >1.2 IU/ml after 14 years; (n = 12)	N/A	[82]
PrEP 3-dose + booster	USA	0, 7, 28 +1 or 2 booster at 390 (1-1-1)+1 or (1-1-1)+2	100% by Day 28; (n = 83)	Well tolerated; most frequently reported concomitant medical condition ‘allergy’ (n = 6/83, 7.2%)	[34]
PEP 5-dose Essen Comparison of Rabipur manufactured in India vs Rabipur manufactured in Germany	India	0, 3, 7, 14, 30 (1-1-1-1-1)	Noninferior and consistent between all batches and lots 100% by Day 14; (n = 254, India); (n = 86, Germany)	At both sites: well tolerated, mild pain at injection Pain: Indian batches (n = 83/252, 33%), German batches (n = 28/85, 33%)	[41]
PrEP 3-dose Comparison of two dilution volumes (1.0 ml and 0.5 ml) of full antigenic dose of Rabipur	India	0, 7, 28 (1-1-1)	100% RVNA ≥0.5 IU/ml by Day 49 (n = 24)	At both sites: well tolerated, mild pain at injection Pain – mild: 0.5 ml (n = 3/38, 7.9%), 1.0 ml (n = 4/38, 10.5%) Myalgia: 0.5 ml (n = 3/38, 7.9%), 1.0 ml (n = 4/38, 10.5%)	[102]
PEP 4-dose Zagreb	China	0, 7, 21 (2-1-1)	100% by Day 14 and Day 45; (n = 32)	Well tolerated, mild and moderate pain at injection Pain: n = 5/96 (5.2%) Malaise: n = 5/96 (5.2%)	[49]

IM: Volume per dose for Rabipur = 1.0 ml.

^†Current Essen regimen recommended by the WHO is a 5-dose IM regimen on Days 0, 3, 7, 14 and 28.

^‡Formerly part of Yugoslavia.

ERIG: Equine rabies immunoglobulin; HDCV: Human diploid cell vaccine; HRIG: Human rabies immunoglobulin; IM: Intramuscular; PCECV: Purified chick embryo cell-culture vaccine PEP: Post-exposure prophylaxis; PrEP: Pre-exposure prophylaxis; RVNA: Rabies virus neutralizing antibody.

Table 2. Summary of Rabipur intradermal PEP and PrEP immunogenicity studies in adults.

Regimen	Country	Testing days (dose series)	Immunogenicity Adequate immune response (RVNA ≥0.5 IU/ml)	Safety	Ref.
PrEP 3-dose PrEP 1-dose booster	Thailand	0, 7, 21 (1-1-1) 0 (1)	100% by Day 21; (n = 24) 100% by Day 21; (n = 7)	Well tolerated, mild systemic adverse reactions	[93,94,96,97]
PEP Oxford 8-site +/- RIG PEP exploratory 4-site +/- RIG	Thailand	0, 7, 28, 91 (8-4-1-1) 0, 7, 28, 91 (4-4-1-1)	100% by Day 14; (n = 30) 100% by Day 21; (n = 46)	ID administration was less painful than IM but caused more local side effects (92%) vs IM group (66%)	[99]
PEP exploratory 4-site	Thailand	0, 3, 7, 28, 90 (4-4-4-1-1)	n = 29 patients (including children; age range 2–61 years): 100% adequate RVNA (≥0.5 IU/ml) at 16 months	Well tolerated, mild systemic adverse reactions	[103]
PEP exploratory 8-dose SC	Thailand	0, 3, 7, 30 (4-2-1-1) 0, 3, 7, 30, 90 (2-2-2-1-1)	100%; (n = 20) 100% in all but one healthy volunteer (SC group); (n = 19)		[104]
PEP Thai Red Cross 2-site	Thailand	0, 3, 7, 30, 90 (2-2-2-1-1)	100% at Day 14; (n = 65)	Well tolerated; no SAEs	[105]
PEP Thai Red Cross 2-site +/- HRIG	Thailand	0, 3, 7, 28, 90 (2-2-2-1-1)	100% by Day 14 until Day 36; (n = 133) RVNA response was significantly higher in patients who received Rabipur + HRIG	Rabipur alone vs + HRIG, most frequent adverse events were erythema (n = 81 vs 52, respectively); itching (n = 53 vs 32, respectively); induration (n = 51 vs 33, respectively)	[54]
PEP Thai Red Cross 2-site	Thailand	0, 3, 7, 30, 90 (2-2-2-1-1)	100% by Day 14; (n = 79)	Reported AEs in 48% (ID) vs 33% (IM). AEs included erythema, pain and/or swelling at injection site and fever	[52]
PEP Oxford 8-site +/- RIG	India	0, 7, 28, 90 (8-4-1-1)	100% adequate RVNA (≥0.5 IU/ml) by Day 7 and maintained at all time-points during the 3-year observation period; (n = 32) (n = 10 children)	Well tolerated, mild pain at injection	[106]
PEP Thai Red Cross	India	0, 3, 7, 28, 90 (2-2-2-1-1)	100% by Day 10 and on all days tested; (n = 42)	Well tolerated, mild pain at injection	[107]
PEP Thai Red Cross + HRIG at Day 0	Czech Republic	0, 3, 7, 30, 90 (2-2-2-1-1)	100% by Day 14; (n = 165)	Well tolerated, no SAEs	[51]
PEP Thai Red Cross	India	0, 3, 7, 28, 90 (2-2-2-1-1)	100% by Day 14; (n = 53)	Well tolerated, mild pain at injection, no SAEs	[108]
PEP ID exploratory 2-site PEP IM 5-dose Essen	India	0, 3, 7, 14, 28 (2-2-2-2-2) 0, 3, 7, 14, 28 (1-1-1-1-1)	100% from Day 14 to Day 365; (n = 45) 100% from Day 14 to Day 365; (n = 46) The mean RVNA concentrations in the IM group were significantly higher vs the ID group from Day 14 to Day 365	All AEs were transient	[109]
PEP exploratory 4-site	Lithuania	0, 7, 30, 90 (4-2-1-1)	100% by Day 14 up to Day 104; (n = 91)	Well tolerated, mild pain at injection, no SAEs	[110]
PEP Thai Red Cross 2-site	India	0, 3, 7, 30, 90 (2-2-2-1-1)	100% by Day 14; (n = 58)	Well tolerated, mild pain at injection, no SAEs	[111]
PEP exploratory 4-site	India	0, 3, 7 (4-4-4)	100% from Day 14 to Day 180; (n = 80)	Well tolerated, mild pain at injection, no SAEs	[112]

ID injection = 0.1 ml per single dose.

IM injection = 1.0 ml per single dose.

ERIG: Equine rabies immunoglobulin; HDCV: Human diploid cell vaccine; HRIG: Human rabies immunoglobulin; ID: Intradermal; IM: Intramuscular; PEP: Post-exposure prophylaxis; PrEP: Pre-exposure prophylaxis; RIG: Rabies immunoglobulin; RVNA: Rabies virus neutralizing antibody; SAEs: Serious adverse events; SC: Subcutaneous.

Table 3. Rabipur PEP and PrEP immunogenicity and safety studies in children.

Regimen	Country	Testing days (dose series)	Age range	Immunogenicity Adequate immune response (RVNA ≥0.5 IU/ml)	Safety	Ref.
PrEP IM 3-dose (1.0 ml) PrEP IM 3-dose (0.5 ml)	Thailand	0, 7, 28 (1-1-1) 0, 7, 28 (1-1-1)	2–15 years	100% on Day 14; (n-11) 100% on Day 14; (n = 13) No significant difference was observed between the two doses	No SAEs	[57]
PEP IM 5-dose Essen PEP IM 6-dose Essen	India	0, 3, 7, 14, 30 (1-1-1-1-1) 0, 3, 7, 14, 30, 90 (1-1-1-1-1-1)	1–13 years	100% 10–15 days post last injection; (n = 271)	Safety (n = 271). Well tolerated, overall mild to moderate reactions (n = 19)	[65]
PEP IM 5-dose Essen	India	0, 3, 7, 14, 30 (1-1-1-1-1)	8 months–16 years	100% on Day 14; (n = 39) No significant difference between groups stratified by protein energy malnutrition grade	No SAEs	[63]
PrEP ID 2-dose PrEP ID 3-dose	Thailand	0, 28 (1-1) 0, 7, 28 (1-1-1)	4–8 years	98% on Day 49; (n = 43) 100% on Day 49; (n = 30)	No SAEs	[60]
PrEP IM 3-dose (1.0 ml) PrEP IM 3-dose^†(0.5 ml)	India	0, 7, 28 (1-1-1) 0, 7, 28 (1-1-1)	6–13 years	100% on Day 49; (n = 57) 100% on Day 49; (n = 58)	No SAEs	[58]
PrEP IM 3-dose (1.0 ml) PrEP IM 3-dose (0.5 ml) PrEP ID 3-dose (0.1 ml) PrEP ID 2-dose (0.1 ml) + JEV	Thailand	0, 7, 28 (1-1-1) 0, 7, 28 (1-1-1) 0, 7, 28 (1-1-1) 0, 28 (1-1) 0, 28 + 0, 7 (JEV) (1-1) + (1-1)	12–18 months	100% on Day 49 and Day 365; (n = 44) 100% on Day 49 and Day 365; (n = 45) 100% and 97% on Day 49 and Day 365; (n = 44) 100 and 61% on Day 49 and Day 365; (n = 44)	Well tolerated, no SAEs	[59]
PrEP IM 3-dose^‡	Kenya	0, 29, 57 (1-1-1)	12–47 months	No rabies immunogenicity. (n = 183) children received Rabipur	Well tolerated, most common AE was fever (31%)	[62]

ID injection = 0.1 ml per single dose.

IM injection = 1.0 ml per single dose.

^†Full dose of vaccine reconstituted in 0.5 ml diluent.

^‡PrEP IM 3-dose was used as a comparator in a malaria vaccine candidate study.

AE: Adverse event; ERIG: Equine rabies immunoglobulin; HDCV: Human diploid cell vaccine; HRIG: Human rabies immunoglobulin; ID: Intradermal; IM: Intramuscular; PEP: Post-exposure prophylaxis; PrEP: Pre-exposure prophylaxis; RIG: Rabies immunoglobulin; RVNA: Rabies virus neutralizing antibody; SAE: Serious adverse events; SC: Subcutaneous.

Table 4. Rabipur immunogenicity in HIV-infected individuals.

Regimen	Country	Testing days (dose series)	Immunogenicity Adequate immune response (RVNA ≥0.5 IU/ml)	Ref.
PEP IM 5-dose Essen	India	0, 3, 7, 14, 30 (1-1-1-1-1)	25% on Day 14 for symptomatic patients with HIV; (n = 30) 25% on Day 14 for asymptomatic patients with HIV; (n = 30) 100% on Day 14 for healthy patients; (n = 30)	[79]
PEP ID exploratory 8-site	Thailand	0, 3, 7, 14, 30 (8-8-8-8-8)	100% by Day 14 for HIV-positive patients; (n = 27)	[113]

Studies are presented in chronological order.

ID: Intradermal; IM: Intramuscular; PEP: Post-exposure prophylaxis; RVNA: Rabies virus neutralizing antibody.

Table 5. Rabipur PrEP immunogenicity following a booster dose in adults and children.

Regimen	Country	Testing days (dose series)	Immunogenicity Adequate immune response (RVNA ≥0.5 IU/ml)	Safety	Ref.
Previous PrEP 3-dose (ID or IM) +1 IM booster	USA	0, 7, 28 booster at 756 (1-1-1) +1	Booster dose, 100% increased geometric mean titers (≥1:11) at Day 763; (n = 69)	Tenderness and pain at injection site (∼50%); redness and swelling (∼35%); headaches, slight fever and malaise (∼20%); joint pain (n = 1/69, 1.4%); brief episodes of enlarged nymph nodes (n = 3/69, 4.3%)	[33]
Previous PEP IM + HRIG at Day 0 +1 booster at Day 1100	Croatia	0, 7, 21 booster at 1100 (2-1-1) +1	56% on the same day; high booster response on Day 1114; (n = 44)	N/A	[114]
Previous PrEP 3-dose Rabipur or HDCV +1 or 2 IM booster 1 year later at Day 0 or Day 3	USA	0, 7, 28 booster post 1 year at 0, 3 (1-1-1)+1 or (1-1-1)+2	All healthy adult volunteers who had received HDCV (n = 82) in the primary series developed high RVNA levels in response to the booster dose(s) of Rabipur by Day 7. Levels were maintained ≥0.5 IU/ml by the end of Year 2	No serious adverse events following 1 or 2 booster dose of Rabipur	[38]
Previous PrEP IM or ID 3-dose +1 booster 2 years later +1 booster 14 years later	USA	0, 7, 28 boosters post 2 years and 14 years (1-1-1) +1 +1	100% RVNA titers (≥1:5) after one IM booster after 14 years; (n = 10) 100% 24–45 days after administered another booster; (n = 10)	N/A	[81]
Previous PrEP ID 2- or 3-dose +2 boosters at Day 0 or Day 3, or post 1, 3 or 5 years	Thailand	(1-1)+2 or (1-1-1)+2	100% by Day 14; (n = 337) original 2-doses; (n = 366) original 3-doses	N/A	[61]

ID injection = 0.1 ml per single dose.

IM injection = 1.0 ml per single dose.

HDCV: Human diploid cell vaccine; HRIG: Human rabies immunoglobulin; ID: Intradermal; IM: Intramuscular; PEP: Post-exposure prophylaxis; PrEP: Pre-exposure prophylaxis; RVNA: Rabies virus neutralizing antibody.

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