Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: Interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials.
Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: Interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials.
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DOI：
10.1016/j.vaccine.2022.10.093
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发表时间：
2023-01-09
期刊：
影响因子：
5.5
通讯作者：
Kara, Ates
中科院分区：
文献类型：
--
作者：
Ozdarendeli, Aykut;Sezer, Zafer;Pavel, Shaikh Terkis Islam;Inal, Ahmet;Yetiskin, Hazel;Kaplan, Busra;Uygut, Muhammet Ali;Bayram, Adnan;Mazicioglu, Mumtaz;Unuvar, Gamze Kalin;Yuce, Zeynep Ture;Aydin, Gunsu;Aslan, Ahmet Furkan;Kaya, Refika Kamuran;Koc, Rabia Cakir;Ates, Ihsan;Kara, Ates
Development of safe and effective vaccine options is crucial to the success of fight against COVID-19 pandemic. Herein, we report interim safety and immunogenicity findings of the phase 1&2 trials of ERUCoV-VAC, an inactivated whole virion SARS-CoV-2 vaccine. Double-blind, randomised, single centre, phase 1 and 2 trials included SARS-CoV-2 seronegative healthy adults aged 18–55 years (18–64 in phase 2). All participants, except the first 4 in phase 1 who received ERUCoV-VAC 3 μg or 6 μg unblinded and monitored for 7 days for safety purposes, were assigned to receive two intramuscular doses of ERUCoV-VAC 3 μg or 6 μg (an inactivated vaccine containing alhydrogel as adjuvant) or placebo 21 days apart (28 days in phase 2) according to computer-generated randomisation schemes. Both trials are registered at ClinicalTrials.gov (phase 1, NCT04691947 and phase 2, NCT04824391). Forty-four participants (3 μg [n:17], 6 μg [n:17], placebo [n:10]) in phase 1 and 250 (3 μg [n:100], 6 μg [n:100], placebo [n:50]) in phase 2 received ≥1 dose. In phase 1 trial, 25 adverse events AEs (80 % mild) occured in 15 participants (34.1 %) until day 43. There was no dose-response relationship noted in safety events in ERUCoV-VAC recipients (p = 0.4905). Pain at injection site was the most common AE (9/44;20.5 %). Both doses of ERUCoV-VAC 3 μg and 6 μg groups were comparable in inducing SARS-CoV-2 wild-type neutralising antibody (MNT50): GMTs (95 %CI) were 8.3 (6.4–10.3) vs. 8.6 (7.0–10.2) at day 43 (p = 0.7357) and 9.7 (6.0–13.4) vs. 10.8 (8.8–12.8) at day 60 (p = 0.8644), respectively. FRNT50 confirmed MNT50 results: SARS-CoV-2 wild-type neutralising antibody GMTs (95 %CI) were 8.4 (6.3–10.5) vs. 9.0 (7.2–10.8) at day 43 (p = 0.5393) and 11.0 (7.0–14.9) vs. 12.3 (10.3–14.5) at day 60 (p = 0.8578). Neutralising antibody seroconversion rates (95 %CI) were 86.7 % (59.5–98.3) vs 94.1 % (71.3–99.8) at day 43 (p = 0.8727) and 92.8 % (66.1–99.8) vs. 100 % (79.4–100.0) at day 60 (p = 0.8873), in ERUCoV-VAC 3 μg and 6 μg groups, respectively. In phase 2 trial, 268 AEs, (67.2 % moderate in severity) occured in 153 (61.2 %) participants. The most common local and systemic AEs were pain at injection site (23 events in 21 [8.4 %] subjects) and headache (56 events in 47 [18.8 %] subjects), respectively. Pain at injection site was the only AE with a significantly higher frequency in the ERUCoV-VAC groups than in the placebo arm in the phase 2 study (p = 0.0322). ERUCoV-VAC groups were comparable in frequency of AEs (p = 0.4587). ERUCoV-VAC 3 μg and 6 μg groups were comparable neutralising antibody (MNT50): GMTs (95 %CI) were 30.0 (37.9–22.0) vs. 34.9 (47.6–22.1) at day 43 (p = 0.0666) and 34.2 (23.8–44.5) and 39.6 (22.7–58.0) at day 60, (p = 0.2166), respectively. FRNT50 confirmed MNT50 results: SARS-CoV-2 wildtype neutralising antibody GMTs were 28.9 (20.0–37.7) and 30.1 (18.5–41.6) at day 43 (p = 0.3366) and 34.2 (23.8–44.5) and 39.6 (22.7–58.0) at day 60 (p = 0.8777). Neutralising antibody seroconversion rates (95 %CI) were 95.7 % (91.4–99.8) vs. 98.9 % (96.9–100.0) at day 43 (p = 0.8710) and 96.6 % (92.8–100.0) vs 98.9 % (96.7–100.0) at day 60 (p = 0.9129) in ERUCoV-VAC 3 μg and 6 μg groups, respectively. Two-dose regimens of ERUCoV-VAC 3 μg and 6 μg 28 days both had an acceptable safety and tolerability profile and elicited comparable neutralising antibody responses and seroconversion rates exceeding 95 % at day 43 and 60 after the first vaccination. Data availability Data will be made available on request.
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影响因子：
3.7
作者：
Pavel, Shaikh Terkis Islam;Yetiskin, Hazel;Ozdarendeli, Aykut
通讯作者：
Ozdarendeli, Aykut
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DOI：
10.1016/s1473-3099(20)30831-8
发表时间：
2021-01
期刊：
The Lancet. Infectious diseases
影响因子：
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作者：
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10.1016/s1473-3099(20)30843-4
发表时间：
2021-03
期刊：
The Lancet. Infectious diseases
影响因子：
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作者：
Zhang Y;Zeng G;Pan H;Li C;Hu Y;Chu K;Han W;Chen Z;Tang R;Yin W;Chen X;Hu Y;Liu X;Jiang C;Li J;Yang M;Song Y;Wang X;Gao Q;Zhu F
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Zhu F
DOI：
10.1016/s1473-3099(20)30942-7
发表时间：
2021-05
期刊：
The Lancet. Infectious diseases
影响因子：
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作者：
Ella R;Vadrevu KM;Jogdand H;Prasad S;Reddy S;Sarangi V;Ganneru B;Sapkal G;Yadav P;Abraham P;Panda S;Gupta N;Reddy P;Verma S;Kumar Rai S;Singh C;Redkar SV;Gillurkar CS;Kushwaha JS;Mohapatra S;Rao V;Guleria R;Ella K;Bhargava B
通讯作者：
Bhargava B
影响因子：
7.8
作者：
Pavel STI;Yetiskin H;Uygut MA;Aslan AF;Aydın G;İnan Ö;Kaplan B;Ozdarendeli A
通讯作者：
Ozdarendeli A